Incidence of Modern Alumina Ceramic and Alumina Matrix Composite Femoral Head Failures in Nearly 6 Million Hip Implants

Background: Because of improvements in ceramic materials and manufacturing, the incidence of ceramic failures has decreased over time. Recent concerns with corrosion have contributed to an increase in ceramic ball head utilization. The purpose of this study is to report the incidence of modern alumina bearing failures from a single major ceramic manufacturer in nearly 6 million hip implants and to identify trends in the modes of failure of these implants. Methods: Beginning in the year 2000, CeramTec AG (Plochingen, Germany) began a comprehensive program for reporting and gathering failure data on its products. From January 1, 2000, to December 31, 2013, over 3.2 million pure alumina (PA) and 2.78 million alumina matrix composite (AMC) ceramic ball heads were implanted worldwide. During this period, there were 672 PA and 28 AMC femoral head fractures. The fractures were analyzed with respect to time to failure, head size, and implant factors. Results: The incidence of clinical fractures of modern PA femoral heads and AMC femoral heads was 1 in 5000 (0.0201%) and 1 in 100,000 (0.0010%), respectively (P<.0001). The majority of implant failures (80%) occurred within 48 months following surgery (P<.01). Fractures were usually associated with specific events such as trauma, mismatched components, and dislocations. Large-diameter PA heads were associated with a lower rate of fracture compared to smaller-diameter femoral heads (0.0316% for 28-mm heads vs 0.0080% for heads 32 mm or greater [P<.01]). Similar trends were observed with AMC heads. The neck lengths of the femoral ball heads were also a factor: a short-taper 28-mm ball head was more likely to fracture compared to other neck lengths (P<.01). Conclusion: Modern PA ceramic heads are reliable with extremely low risk of fracture. The reliability is even better with AMC heads. (C) 2016 Published by Elsevier Inc.