During a retrospective case note analysis, a significant difference was found in prosthesis survival, between two cohorts of patients who underwent different total knee replacements. The first cohort included 70 patients who underwent Kinemax Plus total knee replacement, the second cohort included 58 patients who underwent PFC Total Knee replacement. All patients were under the care of one Consultant Orthopaedic Surgeon. Interestingly, the Kinemax Plus cohort was found to have a higher rate of revision compared to the PFC cohort. A detailed comparison was carried out between the two groups to identify any obvious cause for the disparity.

The two cohorts were found to be well matched with respect to age, sex, ASA grade, underlying pathology and operative technique. Median follow up being 6 years and 5 years for the Kinemax Plus and PFC groups respectively.

There were 11 failed prostheses in the Kinemax Plus cohort, 7 undergoing revision with the remaining 4 patients offered revision but unwilling to have surgery. Wear of the polyethylene tibial insert was the most obvious finding at revision, present in six of the seven revisions. 97% of the Kinemax Plus Prostheses were intact at 5 years but by 8 years only 87% were intact. There were no revisions performed in the PFC cohort.

Post-operative x-ray analysis was undertaken to rule out prosthesis malalignment as a cause for the increased failure rate. The coronal alignment of the prostheses (CAK) was calculated and all post operative x-rays were within the normal limits of 4-10 degrees.

Analysis of the explanted Kinemax Plus polyethylene liners was undertaken. In six cases, the polyethylene bearing surfaces displayed severe surface and subsurface delamination. This suggests massive fatigue and fatigue wear. Only one implant showed localised delamination.

These findings suggest the hypothesis of weak polyethylene particle interface strength.

The Kinemax Plus knee replacement has a reported 10 year survival of around 96%. However we found the survival rate of this implant in our cohort to be 75% at 9 years. No abnormalities were found for clinical and radiological parameters. At reoperation the most striking feature was that of significant ultra-high molecular weight polyethylene (UHMWPE) failure. Oxidative and structural analysis of the polyethylene components was therefore undertaken.

Ten Kinemax Plus tibial inserts were analysed; one was a shelf-aged unused implant, the others were explants. An FTIR analysis of the data showed that oxidation is present in all samples. The degree of oxidation however varied with depth and location. Except for a sharp oxidative peak approximately half way into the sample, the shelf aged samples had a fairly constant level of oxidation. The retrieved implants had an overall higher level of oxidation in both bearing and non-bearing regions. The latter had less of a variation in oxidation which implies that in vivo loading exaggerates the degree of oxidation. In the non-articulating regions oxidation of the explants was found to peak often at the region of about 40% from the bottom surface in all retrieved samples. By contrast, most articulating region had two oxidative peaks; one occurring at approximately 1–1.5mm from the surface, which is consistent with findings on subsurface oxidation, and another occurring about 2–3mm from the bottom surface.

SEM imaging provided evidence for the presence of fusion defects by indicating grain boundaries through-out the explants. This indicates a compromised material which is more susceptible to damage. Fatigue loading of the implant has also been seen to produce a subsurface stress maximum at approximately 1 to 2mm below the articulating surface. It is thought that maximum contact stresses within this region cause Type 1 and Type 2 defects to open or become more pronounced. This in turn will increase the local concentration of oxygenating material as it will be present in these defects and voids where surface areas are greater for oxidative reaction. We therefore hypothesise that these fusion defects are the cause for the early failure of the Kinemax implants.

We aim to explain the significant difference in survivor-ship found between two cohorts of patients who underwent different total knee replacements. The first cohort included 70 patients who underwent Kinemax Plus total knee replacement, the second cohort included 58 patients who underwent PFC Total Knee replacement. All patients were under the care of one Consultant Orthopaedic Surgeon.

Interestingly, the Kinemax Plus cohort was found to have a higher rate of revision as compared to the PFC cohort. A detailed comparison was then carried out between the two groups to identify any obvious cause for the disparity.

The two cohorts were found to be well matched with respect to age, sex, ASA grade, underlying pathology and operative technique. Median follow up being 6 years and 5 years for the Kinemax and PFC groups respectively. There were 11 failed prostheses in the kinemax cohort, 7 undergoing revision with the remaining 4 patients offered revision but unwilling have surgery. Wear of the polyethylene tibial insert was the most obvious finding at revision, present in six out of the 7 revisions. 97% of the Kinemax Plus Prostheses were intact at 5 years but by 8 years only 87% were intact.

There were no revisions performed in the PFC cohort.

Post operative x-ray analysis was undertaken to rule out prosthesis misalignment as a cause for the increased failure rate. The coronal alignment of the prostheses (CAK) was calculated and all post operative x-rays were within the normal limits of 4–10 degrees.

Analysis of the explanted Kinemax Plus polyethylene liners was undertaken. In six cases, the polyethylene bearing surfaces displayed severe surface and subsurface delamination at both medial and lateral sides. This suggests massive fatigue and fatigue wear. Only one inplant showed localised delamination. The surface characterisation suggests the hypothesis of weak UHMWPE particle interface strength.

We describe a cohort of patients with a high rate of mid-term failure following Kinemax Plus total knee replacement inserted between 1998 and 2001. This implant has been recorded as having a survival rate of 96% at ten years. However, in our series the survival rate was 75% at nine years. This was also significantly lower than that of subsequent consecutive series of PFC Sigma knee replacements performed by the same surgeon. No differences were found in the clinical and radiological parameters between the two groups. At revision the most striking finding was polyethylene wear. An independent analysis of the polyethylene components was therefore undertaken. Scanning electron microscopy revealed type 2 fusion defects in the ultra-high molecular weight polyethylene (UHMWPE), which indicated incomplete boundary fusion. Other abnormalities consistent with weak UHMWPE particle interface strength were present in both the explanted inserts and in unused inserts from the same period.

We consider that these type 2 fusion defects are the cause of the early failure of the Kinemax implants. This may represent a manufacturing defect resulting in a form of programmed polyethylene failure.