Abstract
Modularity of femoral components has been widely accepted at the head neck junction, most commonly combining two unlike metals with only sporadic reporting of compatibility issues and corrosion. The development and introduction of a new and improved modular neck junction (Rejuvenate Modular Femoral component, Stryker Orthopedics) provided the option of fine-tuning leg lengths, offset and stability. The surgical technique did indeed provide the desired endpoints, however, the early recognition of problems with the junction causing corrosion and Adverse Local Soft Tissue Reaction (ALTR) and subsequent revision has led to the product being voluntarily withdrawn from the market. My experience as an early user of this stem is described in this manuscript providing a better early recognition and treatment of this potentially very destructive process.
Methods
A retrospective review of one hundred and ninety one Rejuvenate Stems that were implanted between January 2010 and January of 2012. However, after March 2011, this stem was only used on those patients who had a rejuvenate stem on the contralateral side. They were all implanted through a mini posterior incision with the first 82 patients receiving a Tritanium cluster hole cup (Stryker Orthopedics) with between two and three screws. The remaining 109 patients had an ADM (Anatomic Dual Mobility, Stryker Orthopedics). All patients were allowed to bear weight as tolerated and were followed up with Xrays at six weeks and one year. Clinical visits were recorded at 2 weeks and 6 months postop. Additional follow up was scheduled every two years following the first annual visit.
Results
One hundred and seventy four of the 191 hips were available for review at the one-year follow-up. Fourteen patients have undergone revision of the hip due to increased pain and formation of an avascular pseudo capsule due to corrosion at the neck stem junction. All patients have demonstrated a black flaky residue at the taper junction and all have had a large, tense effusion with a milky colored fluid. A neo caspsule has formed in all patients that appeared avascular and thickened. Seven of the eight tritanium cups in the revision cases were loose and required revision, while none of the ADM cups were loose. One patient has undergone two revisions since the initial cause of failure was not recognized and she subsequently developed pain within three months following placement of a new modular neck at the initial revision. One patient who underwent revision developed a deep infection and is currently on antibiotics but has not cleared the infection as of this writing.
Conclusion
There has been catastrophic early failure of a modular femoral component due to corrosion at the neck stem junction during the very early stages of follow up. An intense reaction appears to begin early on, perhaps contributing to failure of bony ingrowth in certain cup designs but not others. Patients who develop early onset of discomfort progress to a poorly functioning hip that presents with pain, swelling and decreased ROM. These patients need to be assessed with serum ion levels, joint aspiration for infection and ion levels if possible. A MRI with MARS technology is useful in identifying joint fluid and neo caspsule expansion. These patients should be advised on the adverse reaction that can develop and revision of the hip should be expeditiously carried out.