Mechanical failure of distal femur mega prosthesis due to polyaryl-ether-ether-ketone (PEEK) hinge component

Background: Polyaryl-ether-ether-ketone (PEEK) has gained popularity as a substrate for orthopaedic hardware due to its desirable properties such as heat and deformation resistance, low weight, and ease of manufacturing. However, we observed a relatively high failure rate of PEEK-based hinges in a distal femur reconstruction system. In this study, we aimed to evaluate the proportion of patients who experienced implant failure, analyse the mechanism of failure, and document the associated clinical findings. Methods: We conducted a retrospective cohort study, reviewing the medical charts of 56 patients who underwent distal femur resection and reconstruction with a PEEK Optima hinge-based prosthesis between 2004 and 2018. Concurrently, we performed a clinical and biomechanical failure analysis. Results: PEEK component failure occurred in 21 out of 56 patients (37.5%), with a mean time to failure of 63.2 months (range: 13–144 months, SD: 37.9). The survival distributions of PEEK hinges for males and females were significantly different (chi-square test, p-value = 0.005). Patient weight was also significantly associated with the hazard of failure (Wald’s test statistic, p-value = 0.031). Discussion: Our findings suggest that PEEK hinge failure in a distal femur reconstruction system is correlated with patient weight and male gender. Retrieval analysis revealed that failure was related to fretting and microscopic fractures due to cyclic loading, leading to instability and mechanical failure of the PEEK component in full extension. Further assessment of PEEK-based weight bearing articulating components against metal is warranted.