Introduction. Metal-on-Metal (MoM) bearing surfaces were historically used for young patients undergoing total hip arthroplasty, and remain commonplace in modern hip resurfacing. In theory, it has been postulated that metal ions released from such implants may cross the placental barrier and cause harm to the fetus. In light of this potential risk, recommendations against the use of MoM components in women of child-bearing age have been advocated. The purpose of this systematic review was to evaluate: 1) the Metal-on-Metal bearing types and ion levels found; 2) the concentrations of metals in maternal circulation and the umbilical cord; and 3) the presence of abnormalities in the fetus. Methods. A comprehensive literature review was conducted of studies published between January 1st, 1975 and April 1st, 2019 using specific keywords. (See Fig 1). We defined the inclusion criteria for qualifying studies for this review as follows: 1) studies that reported on the women who experienced pregnancy and who had a Metal-on-Metal hip implant; 2) studies that reported on maternal metal ions blood and umbilical cord levels; and 3) studies that reported on the occurrence of fetal complications. Data on cobalt and chromium ion levels in the maternal blood and umbilical cord blood, as well as the presence of adverse effects in the infant were collected. Age at parturition and time from MoM implant to parturition were also collected. A total of 6 studies were included in the final analysis that reported on a total of 21 females and 21 infants born. The mean age at parturition was 40 years (range, 24–41 years), and the mean time from MoM implantation to parturition was 47.2 months (range, 11–119 months). Results. Maternal blood cobalt levels were found as a weighted average of 33.94ug/L (0.972–143), while umbilical cord blood cobalt levels were found to be 22.07 ug/L(0.486–75). Cobalt levels were reduced by an average of 35% between maternal and umbilical cord blood. Maternal cord blood chromium levels were found as a weighted average of 9.25 ug/L (1–25), while umbilical cord chromium levels were found to be 1.30 ug/L(0.288–2.3). Chromium levels were reduced by an average of 86% between maternal and umbilical cord blood. No cobalt or chromium was detected in the umbilical cord blood of three patients. Out of the 21 infants born to women with MoM implants, 20 were born healthy with no adverse effects or complications. Conclusion. To date, there is a lack of consensus as to whether Metal-on-Metal hip arthroplasty implants are to be avoided in the child-bearing female population and whether it constitute a hazard to the fetus in-utero. Both chromium and cobalt ions were markedly reduced in levels when transitioning from maternal to cord blood. In particular, chromium showed a greater reduction on average than cobalt (86% vs. 35%). Based on the current evidence, there appears to be no correlation between the presence of metal ions in umbilical cord blood and complications, particularly congenital malformations in the fetus, as none of the infants experienced abnormalities uniquely attributable to the presence of metal ions. For any figures or tables, please contact the authors directly

The relevance of fluid-film lubrication, elasto-hydrodynamic lubrication and ‘tribolayers’ for hip bearings has been the subject of much debate (Fisher 2012). However, knowledge of the thickness and distribution of proteins in and around the wear zone of metal-on-polyethylene (MPE) bearings is scant. The efficacy of protein lubrication with metal-on-metal bearings (MOM) is in discovery. This simulator study was designed to analyze film formation on MOM bearings using varied protein concentrations. The hypotheses were that increasing protein concentrations in the serum lubricant would result in 1) greater thickness of protein films, and 2) reduced MOM wear. The hip simulator was run for 5 million cycles (5 Mc) duration using 28 mm MOM bearings (DJO Inc) run with the cups anatomical. Lubricant protein concentrations were 16.5, 33, and 66 mg/ml. At each test interval of 1 Mc, the proteins films on CoCr surfaces were analyzed by both interferometry and SEM imaging in main-wear, transition-wear and non-wear zones. Thickness of protein films was measured using non-contacting interferometry. Areas of wear zones were mapped and measured and the areas compared. MOM wear rates were assessed gravimetrically. It was found that the proteins formed two types of film (Figure 1). Type-1 was visually hazy in appearance, grainy in structure, and most commonly found in the main-wear zone. This type of protein film was always present in the main-wear zone but its thickness (approximately 0.05 μm) did not increase with increase in the lubricant protein concentrations. Type-2 was visually rainbow-like in appearance, more gel-like with thick clumps appearing as islands on the CoCr surfaces, and more common in the transition zone. This type of film was always present (approximately 1 μm thick) and its thickness notably increased in cups with increased lubricant protein concentrations. This film remained relatively consistent on femoral heads and did not change with increased protein concentrations (Figure 2). The type-1 protein films were always detectable in the actual wear zones but only the type-2 film showed a build-up with protein concentration and only inside the cups. This may be partially a response to the orbital simulator set up. In the Anatomical test mode, the cup is fixed with respect to the load axis and the head oscillates. Thus the main-wear zone on the head had a distributed type of wear patch and the main-wear zone in the cup was fixed. This configuration would allow the type-2 proteins to accumulate around the edge of the cup wear zone. In contrast, they would be scraped off the wear zone of the orbiting femoral head. This study showed that protein films endure even inside the main-wear zone of MOM bearings. In addition, collaborative studies have shown that the protein films are highly mobile and stream across the main-wear zones. Thus there is both an interaction with the CoCr surfaces and a degradation phenomenon that likely results in the protein-rich layers in the transition regions. Figure 1: SEM images of type 1 and type 2 protein films. Figure 2: Protein films on MOM bearings under three different protein concentrations

Metal-on-metal hip arthroplasty has fallen out of favor because of complications arising from the articulation, namely metal sensitivity and accelerated wear. These complications can lead to early/mid-term failures from pain, osteolysis, implant loosening, and pseudotumor formation. However, it has become clearer that MOM total hip arthroplasty behaves differently from MOM hip resurfacing, due to the additional junctions present in the total hip arthroplasty setting. Garbuz et al have demonstrated in a randomised controlled trial that MOM THA has significantly higher metal ion levels than MOM hip resurfacing. Clinical results of a MOM THA compared with a MOM HR using the same articulation also demonstrate significantly poorer results with the THA. Newer literature has also shown that corrosion occurs at the taper junction of a THA due to the dissimilar metals. These corrosion products are likely what are causing a higher incidence of adverse local tissue reactions. Because a hip resurfacing implant is a monoblock ball, there is no taper junction of dissimilar metals that has the potential for corrosion. National registry studies have also demonstrated a difference in the survival curves of MOM THA vs. hip resurfacing. MOM HR, in select patient groups, has a lower revision rate at 10 years than traditional metal-on-poly THA. Thus, to eliminate MOM hip resurfacing as a treatment option is akin to “throwing the baby out with the bathwater”, which the presenter deeply opposes

Introduction. Metal on metal hip resurfacing (MoM HR) is attractive for young active patients. Patients with osteonecrosis of the femoral head (ONFH) are relatively young. HR can be an option of treatment, however, long-term stability of the femoral component is a concern because of the necrotic lesion in the femoral head. There is also a concern of ARMD for MoM implants. The purpose of this study is review a 10 year outcome of a consecutive patients with ONFH who underwent MoM HR. Methods. The subjects of this study were 30 hips of 26 patients with ONFH who underwent HR between 1998 and 2004. There were 21 hips of 18 males and 9 hips of 8 females. The average age at operation was 40 years (range, 20–63 years). 19 ONFHs were induced by steroid and 11 ONFHs were alcohol related. According to the Japanese Investigation Committee classification, there were 8 hips with Type C1 and 22 hips with Type C2. There were 16 hips in stage 3A, 7 hips in Stage 3B, and 7 hips in Stage 4. Operation was performed through a posterior approach. A fragile necrotic bone was curettage thoroughly and the defect was filled with cement. Results. The average Harris hip score improved from 61 preoperatively to 97 at the final follow-up. The average radiographic inclination of the cup was 43 degrees (34–54 degrees) and the average anteversion was 12 degrees (4– 22 degrees). There was no dislocation. One hip had a late hematogenous infection at 9 years after surgery. Two hips of two patients with alcoholic ONFH had a mechanical loosening of the femoral component at 10 year and 13 years after surgery. The survivorship with revision for aseptic loosening as the endpoint was 96% at 10 years. There was no ARMD by ultrasound echo screening. There was no stress shielding of the femur at the final radiographic examination. Conclusion. Our over 10 year results of MoM HR for ONFH showed a high Harris hip score without dislocation. Although this series included the initial learning curve of the HR procedure, the survivorship with revision for aseptic loosening as the endpoint at 10 years was high. There was no ARMD by ultrasound echogram. MoM HR is a good option of treatment for ONFH

This study of retrieved 28 mm Metasul™ (cemented) revealed for the first time adverse wear effects created by impingement-subluxation in MOM. The 10 cases selected (with femoral stems) had annual follow-up 3–11 years. (1) Unequivocal evidence here shows that all heads routinely subluxed from the Metasul liners. Femoral stems revealed well-demarcated notches (DN) on necks and trunnions (Fig. 1a: n = 6), shallow cosmetic blemishes (Fig. 1b CB: n = 4), and abrasion by cement (Fig. 1b: PMMA). As demonstrated by EOS radiographs, impingement locations varied with implant positioning, pelvic mobility and patient functionality – both anterior and posterior notching (Fig. 1). The first impingement notch occurred with head located (Fig. 2a), whereas the head had subluxed from the cup at 2. nd. notch (Fig. 2b). The model demonstrated that patients gained 20° motion by such head-subluxation manoeuvres. It was surprising that there was no collateral damage evident on the liners. Even with severe notching of Ti6Al4V and CoCr stems, the cup rims generally appeared well-polished. Femoral heads revealed macro-stripe damage on articular surfaces (Fig. 3), as did cups. Basal and polar macro-stripes on heads were always located at hip impingement positions. The equatorial stripes were formed at main-wear zone boundaries. Thus equatorial stripes were likely created by some form of rim-impact damage (micro-separation) or by local ingress of 3. rd. -body wear particles under the cup rim. Micro-grooving was evident within these macro-size stripes and frequently featured large raised lips (Fig. 3), interpreted as signs of adverse 3. rd. -body wear mechanisms, and rarely described.(2) It would appear that large metal particulates were released during MOM impingement-subluxation manoeuvres and circulated the hip joint to producing severe 3. rd. -body abrasion. Gradual decomposition of such large debris to nano-sized particulates under joint loading would then produce the often-referenced ‘self polishing’ effect of CoCr. EDS studies revealed metal smears on the CoCr surfaces containing the elements of titanium alloy (Ti, Al, V). This was further evidence of impingement-subluxation manoeuvres.(1, 3). In-vivo cup wear patterns also appeared much larger than those produced in MOM simulators. Such differences likely reflected head-subluxation in vivo, whereby heads unconstrained by the subluxation maneuver were free to orbit up and even cross cup rims, i.e. “edge wear”. This appears to be the first study detailing the adverse wear mechanisms in MOM bearings. There are two limitations to our retrieval study, a) these wear results may not be representative for all MOM designs, and b) it is unknown whether such results have relevance to MOM cases continuing successfully

Purpose. There are some concerns about doing hip resurfacing arthroplasty in ONFH due to bone defect which can cause mechanical weakness of femoral component and highly active young age of patients which can cause high wear rate and failure rate. The purpose of this study is to verify the HRA is safe procedure in ONFH in the aspect of mechanical and biological issue. Materials and Methods. Between December 1998 and May 2005, 185 hips of 169 patients underwent MoM HRA using Birmingham Hip Resurfacing System® at single center. 166 hips (26 hips of female, 140 hips of male) of 144 patients have been reviewed for at least 7 years after MoM HRA. Mean follow-up period was 101.8 (84–178) months. Their mean age at the time of operation was 37.7(16–67) years old. Clinically, Harris hip scores (HHS), UCLA activity scores and range of motion were evaluated. Radiologically, the extent of necrotic area in preoperative MRI and radiolucency around implants, narrowing of retained neck, impingement, stress shielding, and heterotopic ossification were evaluated in the serial anteroposterior and groin lateral radiographs of hip. Complications were defined as joint dislocation, infection, implant loosening, femoral neck fracture and pseudotumor. Failure was defined as revision arthroplasty due to the complications. Results. The extent of necrotic area in preoperative MRI was average 37.6 (13.3–65)%. Clinically, average HHS was improved from 81.7 points to 98.5 points at last follow-up. Average UCLA activity score at last follow-up was 9.0 points. Range of motion at last follow-up was very satisfactory. There was no patient with severe pain around hip joint. Radiologically, radiolucency was shown around acetabular component in 2 cases (1.2%) and around stem of femoral components in 3 cases (1.8%). Fracture of femoral neck was seen in 1 case(0.6%). Moderate narrowing changes of retained femoral neck were noticed in 4 cases (2.4%). Impingement was seen in 12 cases (7.2%). We found only 1 case of osteolysis at Gruen zone III of acetabulum. Heterotopic ossification was found in 5 cases (3.0%). There was no case with hip dislocation, infection or pseudotumor. Revision surgeries after the primary resurfacing arthroplasty were performed in 4 cases (2.4%). Three hips were revised to the conventional total hip arthroplasty (THA) because of loosening of acetabular component and femur neck fracture. One case of femoral component loosening was revised to THA using big metal head with retained acetabular component. Conclusions. MoM HRA in ONFH demonstrates good survivorship in average 101.8 months follow-up study. Most of patients show excellent clinical results with high level of activity postoperatively. Prevalence of complications is extremely lower than concern including the allergic reaction to the metal ion. There was no mechanical failure related to bone defect due to ONFH. This results suggests that MoM HRA in ONFH less than 50% of extent of necrosis can be justified

Introduction. The failure rate of Total Hip Replacement (THR) has been shown to be strongly influenced by the nature of the articulating interfaces, with Metal-on-Metal (MoM) articulations having three times the failure rate of Metal-on-Polyethylene (MoP) components. It has been postulated that this observation is related to edge wear and increased bearing torque of large MoM heads, which would lead to increased loading and wear at the head taper junction and, subsequently, to the release of metal ions and corrosion products. This suggests that taper wear and corrosion should not be as prevalent in large head MoP implants as in large head MoM implants. This study was undertaken to test the hypotheses that: (i) MoM implants exhibit higher rates of corrosion and fretting at the head taper junction than MoP implants, and that (ii) the severity of corrosion and fretting is greater in components of larger head diameter. Materials and Methods. Our study included 90 modular implants (41 MoM; 49 MoP) retrieved during revision hip arthroplasties performed between 1992 and 2012. Only retrievals with head diameters greater than 32 mm were included, and trunnion sizes ranged from 10/12 mm to 14/16 mm with 12/14 mm being the most common size. The stem trunnion and head taper surfaces were examined under stereomicroscope by a single observer. Each surface was scored for both corrosion (using a modified Goldberg scoring system) and fretting (using the standard Goldberg scoring system). For both the trunnion and head tapers, the student's t-test was used to determine if differences exist in the severity of corrosion or fretting between the MoM and MoP groups and between different head sizes of the same articulation type. Results. Overall, there was no significant difference in the severity of corrosion or fretting damage of femoral head taper surfaces or in the fretting of stem trunions between articulation types (p values: 0.245 to 0.733) or head sizes (p values: 0.333 to 0.680). However, corrosion damage of the trunions did vary with the type of articulation (p = 0.0069) and with head size (p = 0.0145). MoP trunnions were found to have significantly more corrosion damage than MoM trunnions at head diameters greater than 40 mm (p = 0.005). Discussion. The surprising conclusion of this study is that the severity of trunnion corrosion in MOP articulations, which surpassed the tribo-corrosion of MOM joints, especially when the prosthetic head size exceeded 40 mm. This conclusion is consistent with the presence of moderate to severe third-body damage in many large diameter polyethylene liners which would lead to a large increase in the frictional torques generated during hip motion. In addition, only part of the loading of the trunnion arises from increased frictional torque. The increase in head size, especially in designs with an offset head center, will lead to increased toggling, and accelerated wear and corrosion of the taper junction, independent of the bearing surface material

Management of pseudotumours associated with MoM THA can be difficult and complications are frequent. The functional outcome of patients after revision surgery may be suboptimal. The objective of this study was to assess our experience with revisions of failed MoM THA due to pseudotumours. 78 hips were diagnosed with pseudotumours in 70 patients following metal-on-metal hip replacements. Of these, 68 MoM THA were revised in 62 patients. Pre operative symptoms, radiographic analysis, metal ion levels, MRI results, intra-operative findings, WOMAC scores, the satisfaction level and the complication rate were recorded. Five patients had a resurfacing arthroplasty as their primary implants while the remaining 63 hips in 57 patients had MoM THA of different brands. The average time between the primary and revision surgery was 69 months (range 15–120). The average age at revision was 59 years (43–87). The mean follow-up was 24 months (range 2–73). 36 patients had minimal one year follow-up. Most lesions consisted of cystic changes and solid lesions were observed in 19 patients. In 57 hips, the pseudotumours were located posteriorly or postero-laterally around the greater trochanter. Intra operatively, muscle necrosis was observed in 15(22%) patients. Most THA cases demonstrated wear and corrosion at the head neck junction of the femoral implants. Thirty-five patients (44.9%) had greater than 50 degrees of cup abduction, including 10 patients (12.8%) with an abduction angle greater than 60 degrees. The average pre operative and postoperative Co ion levels were 27.46 ug/L (range 0.36–145.6) and 2.46 (range 0.4–12.48), respectively. Post revision, a total of 10 hips (14.7%) sustained a dislocation, with seven (10.3%) of them experiencing recurrent dislocations. In 8/10 hips, the femoral head size was 36mm or greater. Revision for dislocation occurred in seven(10.3%) patients. Three(4.4%) deep and one(1.47%) superficial infections occurred and deep infections were re-operated. One(1.47%) fracture of the greater trochanter and one (1.47%) psoas tendinitis did not need revision. Therefore, a total of 10 patients (14.7%) were reoperated. 6 revisions for instability were performed in the first 34 patients, while 1 were done in the last 34 patients. At one year post revision surgery, the mean WOMAC score was 19.68 (range 0–48). In comparison, the mean WOMAC score of the same patients one year after their primary surgery was 8.1 (0–63). Patient satisfaction level of patients one year post revision surgery was 7.61 (range 5–10) compared to 4.15 (range 0–7) pre-revision one. The complication rate after revision of pseudotumours is high. Most re revisions occurred secondary to instability despite the use of larger femoral heads. The functional outcome at one year post revision seems to be lower than that seen after primary THA but similar to other revisions in the literature. Experience in the management of these patients may reduce the complication rate

In an effort to understand the role of metal ion analysis and how it relates to revision surgery and implant wear, four revised MOM cases were reviewed. The first case was revised for acute infection and is representative of the low bearing wear predicted by MOM simulator studies. Two of the four cases had apparent anterior subluxation as a result of hip hyperextension occurring with long stride gaits. The last case is a true hypersensitivity response to CoCr ions. All four MOM prostheses were implanted by one surgeon and revised by the same surgeon approximately 6–8 years postoperatively. The implants had been positioned satisfactorily with inclination angles 45°–55° and anteversion angles 28°–42°. Patient A (76 y/o female) with bilateral MOM hip replacements, was revised at approximately 8 years due to infection and had moderately elevated ions at the time of revision surgery (Co = 5, Cr = 2.3, Ti = 4). Only the femoral head was retrieved in this case. Retrieval analysis identified a well defined main-wear zone and one polar stripe. The CMM indicated there was minimal wear overall (form factor = 11 μm). Patient B (33 y/o male) with bilateral MOM hip replacements, was revised at approximately 8 years due to pain, popping/catching sensations, and elevated ions (Co = 33, Cr = 17, Ti = 90). Intraoperatively, the implant was observed subluxing superiorly from the acetabular cup with anterior rotation of the leg. Both the femoral head and acetabular cup were retrieved. Retrieval analysis identified a well defined main-wear zone and multi-directional polar stripe formations similar to those reported on dislocated implants (Figure 1)[McPherson 2012, 2013]. The CMM indicated that overall wear was significant (form factor > 100 μm). Patient C (77 y/o female) was revised at approximately 6 years due to pain, suspected implant loosening, osteolytic cysts determined by CT, and highly elevated ions (co = 164, Cr = 45, Ti = 33). Intraoperatively, there was evidence of wear including darkly stained tissue and osteolytic cysts. Both the femoral head and acetabular cup were retrieved. Retrieval analysis identified a well defined main-wear zone and one polar stripe. CMM indicated considerable wear (head form factor > 200, cup form factor >300). Patient D (45 y/o female) was revised at approximately 6 years due to pain, apparent reactive response joint effusion, and moderately elevated ions (Co = 5, Cr = 6, Ti = 71). Only the femoral head was retrieved. Retrieval analysis identified a well defined main-wear zone and one polar stripe. Minimal wear was indicated by CMM (form factor = 21). These four cases demonstrate distinct failure models of MOM hips and their respective metal ion results. Due to the diversity of patient location, a variety of clinical labs were utilized for this patient population. Caution should be used in interpreting metal ion analysis, as there are still no standards. Figure 1: Retrieval analysis of stripe wear identified on femoral head from patient B. Figure 2: Femoral head from patient C showing broader polar stripe associated with anterior subluxation in comparison to narrow polar stripe found on femoral head from patient A

Introduction. Hip simulators proved to be valuable, pre-clinical tests for assessing wear. Preferred implant positioning has been with cup mounted above head, i.e. ‘Anatomical’ (Figs. 1a-c) . 1,2. while the ‘Inverted’ test (cup below head) was typically preferred in debris studies (Figs. 1d-f). 3,4. In an Anatomical study, wear patterns on cups and heads averaged 442 and 1668 mm² area, respectively, representing 8% and 30% of available hemi-surface (Table 1), i.e. the head pattern was ×3.8 times larger than cup. This concept of wear patterns is illustrated well in the ‘pin-on-disk’ test (Fig. 1) in which the oscillating pin has the ‘contained’ wear area (CWP) and the large wear track on the disk is the ‘distributed’ pattern (DWP). Hip simulators also create CWP and DWP patterns, site dependant on whether Anatomical (Fig. 1a-c) or ‘Inverted’ (Fig. 1d-f) test. However there is scant foundation as to clinical merits of either test mode. Retrieval studies of MOM bearings have indicated that cups have the larger wear patterns, i.e. contrary to simulator tests running Anatomical cups (Table 1). 5. Therefore we compared Anatomical and Inverted cup modes using 38mm and 40mm MOM in two 5-million cycle simulator studies. Methods. 38mm and 40mm MOM bearings were run in Anatomical mode (study-1) and Inverted (study-2) mode, respectively, in a hip simulator. Lubricant was bovine serum diluted to provide protein concentration 17 mg/ml. Wear was measured gravimetrically and wear-rates calculated by linear regression. Wear patterns were assessed by stereomicroscopy and compared to algorithms using standard spherical equations. Results. MOM wear-rates ranged 0.3 to 6 mm³/Mc by 5-million cycles duration. Contained wear patterns (CWP) averaged 410 mm² for cups in study-1 (Anatomical) and 397 mm² for heads in study-2 (Fig. 3: Inverted). Distributed wear patterns (DWP) averaged 945mm² in study-1 (heads, Anatomical) and 846mm² in study-2 (cups, Inverted). Cup Hemi-ratios averaged 18% and 38% in studies 1 and 2 respectively (Table 2). Discussion. While vendor, implant and experimental differences were clearly present, study-1 (Anatomical) and study-2 (Inverted) produced almost identical CWP and DWP wear patterns, only reversed on heads versus cups. This unequivocal evidence demonstrated that there was no difference in wear mechanics for spherical CoCr bearings run in either test mode. In addition, wear patterns observed in MOM cup retrievals. 5. (1000–2700 mm²) were much larger than produced in Anatomical simulator tests (Fig. 2h: 400–500 mm²). Such large discrepancies in cup wear patterns between Anatomical simulator tests and retrieved MOM cups indicated that the Inverted cup mode (Fig. 2g) may be more clinically relevant

No, not my mother, but metal-on-metal (MoM) hips! My involvement in the DEFENSE side of MoM hips has allowed me the luxury of reflection and continued study on the basic and clinical science of this particular wear couple. Much of what I have learned is relevant to other articular couples, and might help you in your next THR. No amount of in vitro laboratory testing can replicate or predict in vivo behavior of a particular wear couple. (Mother Nature always has something new to teach us!) Although MoM implants went through complete pre-market evaluation and approval in both the US and EU, the process is inadequate and does not assure safety or success of new designs and materials. Two year results obtained in pre-market (IDE) studies are of insufficient follow-up for accurate evaluation of new materials or designs. Be conservative! Be neither the first, nor the last, to embrace new technology!. Clinical experience and retrieval analysis of MoM devices has revealed factors that are not as apparent for other wear couples such as metal-on-polyethylene (MoP), or ceramic-on-ceramic (CoC). For instance:. All THR's are at risk of micro-lateralization, or displacement of the femoral head from the acetabular wear couple during swing phase, resulting in edge loading. In addition, impingement or displacement related to component malposition or failure to balance the soft tissues about the hip can produce subluxation, producing edge loading and accelerated wear. In the case of MoM implants, the tribology and wear properties of MoM produce identifiable wear scars; all MoM designs appear to be subject to these phenomena. However, evidence now exists that both MoP and CoC wear couples are at similar risk for accelerated wear, although at different rates than MoM. Hard-on-hard wear couples (ceramic, metal) are less tolerant of edge loading than hard-on-soft (e.g., MoP or CoP) wear couples, and therefore require a higher degree of surgical precision in implant placement and reconstruction of the soft tissue balance of the hip. One of the previously unrecognised factors that can change relative implant position (and therefore, the risk of subluxation or edge loading) is the effect of the lumbar spine on apparent acetabular component position (e.g., changes between sitting, standing, or lying prone). This is largely due to the effect of lumbar spine flexibility, as shown in both orthogonal x-ray (“EOSr”) studies, and dynamic CAT scan studies. There is currently no validated algorithm or technique to assess these factors; however, surgeon awareness and at least clinical assessment preoperatively may result in better positioning of implants. Femoral component position can also have a major effect of the risk of impingement or subluxation of the femoral head; the combined anteversion concept of Dorr et al. should be rigorously adhered during THR. Other issues such as fretting corrosion associated with large diameter femoral heads and tissue response to wear debris may not be anticipated until a very large cohort population is available for examination and analysis. No matter how extensive in vitro testing may be, only clinical experience and retrieval analysis can provide the ultimate reassurance as to the success of a new design or material

The MOM controversy continues with many prevailing opinions as to the causes of failure in contemporary designs. There has been a great deal of focus on breakdown in fluid-film lubrication with respect to cup positioning and edge wear at its rim. However there has been very little discussion on the problems of 3. rd. body abrasion. In only one study was there a description of unusually large abrasive marks on retrieved femoral heads (McKee Farrar MOM), revealing 100 μm wide scratches, attributed to circulating particles fractured during impingement episodes. With contemporary MOM devices, there is the potential for abrasion by particulates of CoCr, PMMA and Ti6Al4V. However it has been difficult to formulate a coherent simulator model for 3. rd. -body abrasive wear, given the unpredictable nature of impingement damage releasing abrasive particles into the patient's hip joint. Thus this study sought to identify if metal or cement particulates were capable of creating 100 μm wide scratches as seen on retrieved MOM and develop a simulator model for 3. rd. body abrasive testing on MOM bearings. Six 38 mm CoCrMo bearings (DJO Inc., Texas) were run in a12-station hip simulator (SWM, Monrovia, CA) with cups mounted both anatomically and inverted (3 MOM each). The tests were run in standard simulator mode (Paul gait load cycle: 0.2–2 kN, frequency 1 Hz) with the addition of 5 mg of debris particles. Commercially available CoCr (ASTM F75) and titanium alloy (ASTM F136) particles and broken polymerized bone cement particles were used in the size range 50–200 μm. The simulator was run for only 10 cycles and the MOM parts removed for study. All bearings were ultrasonically cleaned and heads were examined using white light interferometry (WLI, Zygo Corp). Grooves were characterized using surface profiles to measure width, depth, and rim height. SEM imaging (EVO MA15, Zeiss) and EDS imaging (X flash detector 4010, Bruker AXS) was performed in areas of grooving and suspected transfer layers. CoCr debris produced broad, curvilinear grooves with widths ranging from 20–170 μm, depths from 0.3–1.5 μm, raised rims, longitudinal striations and chatter marks. Titanium alloy debris produced arrays of very shallow scratches accompanying larger grooves. These larger grooves measured 20–110 μm wide and 0.4–1.9 μm deep. EDS imaging showed the smears and islands contained the elements Ti, Al and V representative of the Ti6Al4V alloy. WLI imaging showed these metal deposits (250–900 um wide) were raised >10 um above the surface. Particularly conspicuous was evidence of considerable smearing on CoCr surfaces, with linear streaks ranging 150–300 μm wide. Bone cement debris proved incapable of grooving the CoCr surface, the only scratches observed were those comparable to normal carbide scratches

The purpose of this study was to determine the survivorship for a MOM implant series performed by a single community surgeon followed using a practical clinical model. A retrospective cohort of 104 primary MOM THA procedures (94 patients) were all performed by one surgeon at three local hospitals now with 10–13 years follow-up. Sixteen patients are deceased and 16 patients have been lost to follow-up. In the remaining 62 patients, 8 are bilateral providing a total of 70 THA for study. The clinical follow-up model included: hip scores, X-rays, ultrasound, and metal ion concentrations (Co, Cr, Ti). Due to the diversity of patient location, a variety of clinical labs were utilized for metal ions. Statistical methods included Kaplan-Meier survival curve and One-way ANOVA. Hip scores were available for 70 THA and of these 61 had a hip score (HHS) above 80 (87%). X-rays were available for 49 hips and of these 38 (78%) had lateral/version angles in the safe zone (Fig 1: inclination ≤ 55 and anteversion ≤ 35). Thirty-eight ultrasound exams were performed and of these three yielded fluid collections (8%). Metal ion concentrations were documented in 39 of 62 patients (63%, either serum or whole blood). Six outliers were identified with high concentrations of metal ions (Fig 2); Co 0.3–143.9 ppb (median 3.6), Cr 0.2–200.3 ppb (median 2.2) and Ti 2-110 ppb (median 54). Six patients were revised by the original surgeon. Three of six with elevated ions were documented as wear problems and the other three were revised for infection, femur fracture and metal-ion sensitivity. The survivorship of 92.5% at 10 years (Fig. 3) may be partly due to the exclusive use of antero-lateral approach performed by one surgeon with 78% of cups well placed and the MOM design used exclusively

Metal-on-metal retrieval studies indicated that MOM wear-rates could rise as high as 60–70mm3/year in short-term failures (Morlock, 2008). In contrast, some MOM and ceramic-on-ceramic (COC) devices of 1970's era performed admirably over 2–3 decades (Schmalzreid, 1996; Shishido, 2003). While technology has aided analysis of short-term MOM and COC failures (Morlock 2008; Lord 2011), information on successful THA remains scant. Lack of long-term data creates difficulties in setting benchmarks for simulator studies and establishing guidelines for use in standards. In this study we compared clinical and wear histories for a 30-year MOM and a 32-year COC to establish such long-term, wear-rates. The McKeeTM retrieval was cemented and made 100% of CoCr alloy (Fig. 1a). This patient had a right femoral fracture at 47 years of age, treated by internal-fixation, which failed. Her revision with a Judet implant also failed, leaving her right hip as a Girdlestone. At the age of 68, she had a McKee THA implanted in left hip, and used it until almost 98 years of age (Campbell, 2003). The COC case was a press-fit AutophorTM THA, head and cup made of alumina ceramic, with the only metal being the CoCr stem (Fig. 1c). This was implanted in a female patient 17-years of age active in sports (water-skiing). This modular THA was revised 32-years later due to hip pain from cup migration. Wear on these implants was identified by stereomicroscopy and stained red for photography (Fig. 1). Cup-to-neck impingement was denoted by circumferential neck notching, roughness was assessed by interferometry, and wear determined by CMM (Lord, 2011). McKee head wear covered 1092mm2 area (Figs. 1a, 2: hemi-area ratio 58%). There was no stripe wear and head roughness was 36nm (Ra). Cup wear covered an area of 1790mm2 (hemi-area 63%). Circumferential damage was noted on the supero-posterior femoral neck with scuff marks also on posterior collar (Fig. 2c). Head and cup wear amounted to 37.7 and 25.2mm3, respectively. Total MOM wear was 62.9mm3, indicating a wear-rate of 2.1mm3/year. Ceramic head wear consisted of two circular patterns (Fig. 1c), the major one of area 1790mm2 (hemi-area 79%). No wear stripes were identified. Non-worn and extensively worn surfaces had roughness (Ra) 17nm and 123nm, respectively. The cup showed 360o circumferential arc of rim wear with a small, non-wear zone inferiorly (Fig. 1c). Gray metallic transfer was evident, EDS revealing Co and Cr (Fig. 3a). Head and cup wear volumes were 77.2 and 54mm3, respectively. Total COC wear amounted to 131.2mm3 indicating a wear-rate of 4.1mm3/year. These two THA functioned successfully over 3 decades. The McKee retrieval had minor signs of impingement but no adverse “stripe wear”. This MOM performed satisfactorily due to good positioning and patient's advanced age (68 to 98Yrs of age). The COC patient was 17 years of age at index surgery and active. The ceramic cup showed 360o of edge wear, CoCr transfer and a COC wear-rate double that of the MOM retrieval. Thus the high ceramic wear-resistance protected this youthful patient

A 35-year-old female (age 35Yrs) had primary MOM total hip arthroplasty (THA) in 2008. At 8 months this patient postoperatively developed headaches, memory loss, vertigo, and aura-like symptoms that progressed to seizures. At 18 months review, she complained of progressive hip pain, a popping sensation and crepitus with joint motion. This patient weighed 284lbs with BMI of 38.5. Radiographs revealed the cup had 55° inclination, 39° anteversion (Fig. 1). Metal ion concentrations were high (blood: Co=126 mcg/L, Cr= 64mcg/L). Revision was performed in November 2010 A dark, serous fluid was observed, along with synovitis. The implants were well fixed and the femoral head could not be removed; thus the stem was removed by femoral osteotomy. With the head fused on this femoral stem, for the 1. st. time it was possible to precisely determine the habitual patterns of MOM wear relative to her in-vivo function. We investigated (1) size and location of wear patterns and (2) signs of cup-stem impingement to help explain her symptoms developed over 32 months follow-up. The retrieved MOM was a Magnum™ with head diameter 50mm and 50×56mm cup (Biomet). This was mounted on a Taperloc™ lateralized porous-coated stem. Components were examined visually and wear damage mapped by stereo-microscopy, interferometry, CMM, SEM, and EDS. Main-wear zone (MWZ) areas were calculated using standard spherical equations. 1. and centroidal vectors determined. The head-cup mismatch was 427um with the cup revealing a form factor of 228um. The cup showed wear area of 1275mm² that extended up to the cup rim over 150°arc. The cup rim was worn thin over a 90° arc with loss of cup bevel. The head showed an elliptical wear area of 2200mm. 2. located centrally on the superior-medial surface (ellipsoidal ratio ×1.2). Compared to the hemispherical surface (50mm: hemi-area = 3927mm. 2. ), the worn area represented hemi-area ratio of 56%. The centroidal vectors measured 8° anterior and 24° superior to the head's polar axis (Fig. 2). Stripe wear damage revealed multiple impingement sites. SEM and EDS revealed stripes were contaminated by metal transfer from the stainless-steel instruments used at revision. The main impingement position was identified (Fig. 3) indicating the site of repetitive subluxations whereby the subluxing head thinned the cup, i.e. “edge wear”. Cup and head wear patterns corresponded well, reinforcing our definition of the MWZ locations in vivo. The femoral MWZ was centrally located superiorly and medially with respect to the polar axis of the femoral neck and head. The noted impingement position indicated this patient had experienced repetitive subclinical subluxations (RSS). 2. The taper inside the fused head may also have been a contributory factor that we cannot ignore. Nevertheless her excessive cup thinning was likely a result of a steep cup and considerable anteversion allowing the femoral head to sublux over the cup rim, thus thinning the cup and wearing the rim bevel, and producing MOM wear debris

INTRODUCTION. The uncertainty of the biological effects of wear and corrosion from Metal-on-metal (MoM) implants has initiated a debate on their safety and use. Generally, the release of wear particles from MoM hip implants can clinically manifest in aseptic osteolysis. In our study, the effect of MoM-wear particles and particle originated Co and Cr ions on mesenchymal stromal cells (MSCs) was investigated [1]. The lead hypotheses were that (1) dissociated Co and Cr, originated from MoM-wear particles, accumulate in the bone marrow and (2) apparently impair the osteogenic function of local MSCs. This impairment could be one element contributing to the manifestation of periprosthetic osteolyses. METHODS. The study was approved by the local ethical committee (EA1/194/13); all donors gave written informed consent. Blood (B), Synovial fluid (SF) periprosthetic tissue (PT) and bone marrow (BM) were collected from patients with at least one osteolytic lesion, undergoing a revision of a MoM hip implant. Patients undergoing primary THA served as controls. Metal wear particles were isolated from PT by enzymatic digestion and their size and shape characterized by transmission electron microscopy (TEM). Local and systemic levels of Co and Cr were analyzed by graphite furnace atomic absorption spectroscopy. MoM-MSCs and control-MSCs were isolated from BM for in vitro assessment of their viability, proliferation, migration and multilineage differentiation. In addition, control-MSCs were in vitro exposed to Co and Cr ions and assessed for their viability, proliferation and osteogenic differentiation. RESULTS. We confirmed the presence of nanoscaled particles that appeared heterogeneous in size and shape (mean diameter: 34.7 ± 16.2 nm; n = 64). Second, we confirmed the exposure to Co and Cr and quantified its particulate and dissociated amounts. Local metal levels exceed systemic ones by several magnitudes and dissociated Co and Cr was found in periprosthetic compartments including BM (peak BM Co concentration: 977 µg/L, peak BM Cr concentration: 2,875 µg/L; n = 10). While in vivo exposure to MoM-wear did not influence MSCs' viability, proliferation, migration capacity, adipogenic- and chondogenic differentiation, it decreased osteogenic matrix mineralization and cellular ALP activity (FIGURE 1). In vitro exposure of control-MSCs to Co(II) and Cr(III) ions, at concentrations detected in BM, confirmed the decrease in osteogenic matrix mineralization and ALP activity (FIGURE 2). DISCUSSION. We found that extensive amounts of Co and Cr occurred in their dissociated state within the periprosthetic region (SF, PT, BM), indicating that vast amounts of particulate wear in degraded. Our work represents an important piece in the puzzle of the clinical manifestation of periprosthetic osteolysis: dissociated Co and Cr at clinically relevant concentrations impair the bone forming function of MSCs. The study's data indicate an influence of MoM-wear on BM residing MSCs' osteogenic differentiation that is relevant for maintaining vital bone structure, thus confirming the lead hypothesis. The use of CoCrMo alloys for articulating surfaces in hip implants needs critical reconsideration. For figures/tables, please contact authors directly.

Retrieval studies of metal-on-metal (MOM) resurfaced hips revealed cup “edge wear” as a common failure mechanism [Morlock-2008]. Retrieval analysis of total hip arthroplasty (THA) also demonstrated extensive rim wear (Fig. 1: 190–220o arcs), typically across the superior cup [Clarke-2013]. Such wear patterns have not been demonstrated in hip simulator studies. The simulator “steep cup” models typically had motion arcs (flexion, etc.) input via the femoral head [Leslie-2008, Angadji-2009]. With fixed-inclination cups this produces constant loading of cup rim against the head (Fig. 2a). This is unlikely to be the physiological norm, unless patients walk constantly on the rims of mal-positioned cups. More likely the patients produce edge-wear intermittently due to functional and postural variations. Therefore a novel simulator model is proposed in which the cup undergoes edge-wear intermittently at one extreme of flexion (Fig. 2a). Our study objective using this new simulator model (Fig. 2a, b) was to (i) demonstrate MOM wear-rates and wear patches as a function of these dynamic-inclinations (40 o, 50 o, 70o), and (ii) compare the simulator data to MOM retrievals (Fig. 1). Two simulator studies were run, both using 60mm MOM. Four bearings were run to 1-million cycles (1Mc) with cups peaking at 40 and 50° dynamic-inclinations, thus providing control data with no edge-wear. In 2nd study, 4 MOM were run with cups given a dynamic-inclination of 70° to produce edge-wear effects. In study-2 currently at 2.5Mc duration, the femoral heads showed the two classical wear phases with run-in at 1.7mm³/Mc and steady-state at 0.084mm³/Mc (Fig. 3a). Wear-rate for cups at 2.34mm³/Mc was 40% higher than heads and continued to rise linearly with time (Fig. 3a). At 2.5Mc, cup wear averaged ×5.7 greater than heads and resulting wear-patterns extended 85°−225° around cup rim (Fig. 3b: average 151°). In study-1, wear patches in cups with 40° dynamic-inclination approached within 12.4mm of the cup rim as denoted by circumferential grooves. This margin-of-safety (MOS) represented a 24°angle. The cup wear-patch averaged area of 1,760mm2. With cups run at 70o dynamic-inclination, the wear patches were transferred an additional 30o towards the rim thereby representing a 6° transfer across the rim. This is the 1st wear study to use the new dynamic-inclination test mode to better simulate cup function in vivo. It was particularly satisfying to see the similarity in wear-patterns between retrieval (Fig. 1) and simulator cups (Fig. 3b). It is also the 1st study to monitor sites and magnitudes of cup wear areas and to purposely produce “edge wear”. The cups with 40° and 50° dynamic-inclinations had large margins of safety. With 70° dynamic-inclination the margin of safety was lost - effectively there was a 6° transfer of the wear patch across the cup rim. Even this apparently small effect at one location in each gait cycle sufficiently perturbed MOM performance that wear increased by an order of magnitude. Notably this was all cup wear and not by femoral head participation. The study continues but at 2.5Mc duration the cups revealed 5-fold greater wear than heads

My involvement in the DEFENSE side of MoM hip litigation has allowed me the luxury of reflection and continued study of the basic and clinical science and voluminous medical and scientific literature concerning this particular wear couple. Much of what I have learned is relevant to other articular couples, and might help you in your next THR. While useful, in vitro laboratory testing cannot wholly replicate or predict in vivo behavior of a particular wear couple. (Mother Nature always has something new to teach us!). Although MoM implants underwent rigorous pre-market testing and evaluation by the industry and appropriate regulatory approval in both the US and EU, the process cannot assure the clinical safety or success of new designs and materials for all implant recipients. Two year results obtained in pre-market (IDE) studies are of insufficient follow-up for accurate evaluation of the short, and certainly medium, or long-term clinical performance of new materials or designs, as demonstrated by the two year data from the Australian Joint Registry. In certain populations, MoM bearings have performed satisfactorily (to date) in individuals for whom traditional bearings were a poor option. Conclusions. Be conservative. Use appropriate clinical judgment and careful informed consent if you recommend new designs or materials to your patient

INTRODUCTION. Metallic ion release may be related to bearing surface wear and thus serve as an indicator of in-vivo performance of metal on metal (MOM) articulations. OBJECTIVES. Compare large head MOM hip components with modular MOM and metal on polyethylene (MOP) to determine their relative effects on serum metal ion levels. METHODS. A prospective controlled trial to compare clinical, radiographic, and serum metal ion concentration (Co and Cr) results between the Large Head ASR XL System (MOM-1), the Ultamet Advanced Modularity System (MOM-2), and the Pinnacle Acetabular Cup System with polyethylene liner (MOP). We enrolled 151 consecutive patients (MOM-1 = 97, MOM-2 = 22, MOP = 32). Radiographs, clinical scores (Harris Hip and WOMAC), and serum ion level assessments (in Parts Per Billion - PPB) were performed pre-operatively and post-operatively (6, 12, and 24 months for all patients and 60 months for MOM-1). At 60 months, we compared WOMAC, Harris Hip scores and serum ion levels (Co and Cr) from MOM-1 (revisions excluded) to 24 month scores from MOM-2 and MOP. After revision, serum ion levels were measured at 1, 3, 6, and 12 months. RESULTS. In MOM-1, 11 patients had significantly elevated ion levels at all postoperative periods (Co AVG 130.35 PPB and Cr AVG 61.46 PPB) after 2 years. Excluding outliers and revised patients, average serum ion levels in the 86 remaining MOP-1 patients at 24 and 60 months were statistically higher than MOP and MOM-2 patients. However, this difference was not clinically relevant (no symptoms, no revisions, Co and Cr AVG below 5 PPB). Table 1. Nine hips (9.3%) in 8 MOM-1 patients required revision and serum ion levels decreased rapidly post-up, but have still not returned to baseline after 1 year. Serum ion levels were not significantly different between MOM-2 and MOP groups at any time. Clinical scores improved after surgery in all groups and continued to improve in MOM-2 and MOP patients after 2 years, but decreased slightly in the MOM-1 patients at 2 and 5 years. Average cup inclination angle did not differ significantly between the groups: MOM-1 50.2, MOM-2 47.8, and MOP 51.7. CONCLUSIONS. We are presenting 5 years of prospectively collected data comparing ion levels among 2 MOM and 1 MOP group, as well as post revision ion levels at 1 year. Average serum ion levels were elevated at all post-operative periods in the MOM-1 group, but this was attributable to significantly elevated levels in a subset of outliers that ultimately required revision. Excluding these outliers, there is a statistically significant but clinically irrelevant difference in post-operative ion levels between MOM-1 vs. MOM-2 and MOP. There was no radiographic evidence of component malposition or aseptic loosening in any group. MOM-2 and MOP performed comparatively across all variables. We present an algorithm to diagnose and manage patients with MOM THA (Yable 2.) and offer evidence that metal ion levels do decrease after revision. Table 3

It has come to light that one significant mechanism for MOM failure may be repeated subluxation or impingement episodes leading to edge wear and release of 3. rd. body particles. This MOM debris-challenge model simulates a patient who experienced one subluxation or impingement event and then continues to walk normally until the next event occurs one week later. Our model assumes that 100–200 particles (debris size 100–200 μm) would be released into the joint space at each subluxation or impingement event. The question then becomes: what is the effect of the patient walking on that single dose of particulates over the next week (or 500,000 cycles in simulator test mode). Nine 38 mm CoCrMo bearings (DJO Inc., Texas) were run inverted in a12-station hip simulator (SWM, Monrovia, CA). The test was run in standard simulator mode (Paul gait load cycle: 0.2–2 kN, frequency 1 Hz) with the addition of 5 mg of debris particles for the first 3 Mc, followed by 10 mg of debris particles from 3–5 Mc. Commercially available CoCr (ASTM F75) and titanium alloy (ASTM F136) particles and broken polymerized bone cement particles were used in the size range 50–200 μm. Serum was changed out every 500,000 cycles and a fresh dose of debris added. All bearings were ultrasonically cleaned and examined using white light interferometry (WLI, Zygo Corp) and SEM (EVO MA15, Zeiss). Wear rates were determined gravimetrically and serum discoloration was noted at each test interval. Titanium alloy and CoCr debris produced darkened serum within the first hour of the test and remained so for the duration (500,000 cycles). Serum color with cement debris remained an opaque golden color throughout the test run. The debris challenge provoked the largest MOM wear response using Ti6Al4V particulates (6.7 mm. 3. /Mc), slightly milder with CoCr particulates (4.5 mm. 3. /Mc) and minimal with PMMA particulates (0.5 mm. 3. /Mc). Compared to bone cement debris chambers (which had wear rates comparable to non abrasive MOM bearing tests), CoCr debris created a 9-fold higher MOM wear and titanium alloy debris created a 14-fold higher MOM wear. These observations indicated that only the metal debris elicited an ‘Adverse’ wear response with MOM bearings