Analysis of Trends in FDA-Recalled Hip Arthroplasty Devices: A Retrospective Review.

Abstract

Hip arthroplasty implants are classified as Class III medical devices by the US Food and Drug Administration (FDA), requiring rigorous evaluation to ensure safety and efficacy. While these standards aim to ensure safety, device recalls remain an essential component of postmarket surveillance to address unforeseen performance issues. The objective of this study was to characterize the frequency, causes, and regulatory origins of FDA-recalled hip arthroplasty implants, identifying trends in device failure and implications for patient safety. A retrospective review of the FDA's medical device recall database was conducted, focusing on implantable hip arthroplasty devices and assistive technology from 2002 to 2024. Data were categorized by device type, recall class, reason for recall, and regulatory approval pathway. Trends over time were analyzed using negative binomial regression. Of 1,863 hip-related recall records screened, 771 implantable devices met inclusion criteria. Design flaws accounted for the most recalls (35.8%), followed by packaging (24.9%) and labelling errors (11.7%). Most recalls were Class II (94.3%) and approved through the 510(k) pathway (94.7%). The number of recalls peaked in 2014 and has declined in recent years (p < 0.001). Robotic-assisted and navigation-related systems accounted for 1.8% of recalls and were frequently associated with software-related design problems (57.1%). Most recalled hip implants were approved through the 510(k) pathway. However, this likely reflects the high volume of devices approved through this mechanism rather than inherent pathway risk. Design-related failures were most prevalent, often involving modular junctions or material degradation. Although robotic and navigation systems currently account for a small minority of recalls, they introduce novel, distinct software-related failure modes that warrant continued postmarket surveillance as these technologies evolve. Level III. See Instructions for Authors for a complete description of levels of evidence.