RESEARCH : Evaluation of Orthopedic Hip Device Recalls by the FDA from 2007 to 2017

Abstract

Background: Medical device recalls have increased in the previous two decades. Orthopedic devices are estimated to constitute 12% of all medical devices recalled. Medical devices enter the market via the Food and Drug Administration's (FDA's) premarket approval (PMA) or 510(k) pathways. This article evaluates orthopedic hip device recalls between Jan. 1, 2007, and Dec. 31, 2017. We hypothesized that the 510(k) approval process would have substantially higher recall rates for defective devices. Methods: The FDA's device recall database was queried for all orthopedic hip devices from Jan. 1, 2007, to Dec. 31, 2017. Each recall included product description, recall number, device class, date of recall posting, date of recall termination, manufacturer, FDA-determined cause for recall, number of recalled units, distribution, product classification, and method of approval [510(k), PMA, or unspecified]. Results: In total, 774 orthopedic hip devices were recalled between Jan. 1, 2007, and Dec. 31, 2017. The 510(k) approval process constituted 85% of hip device recalls. The most common FDA-determined cause of hip device recalls was device design, which constituted 37% of 510(k)-approved device recalls but only 6% of PMA-approved device recalls. The most recalled hip devices were hip prostheses. Orthopedic hip device recalls have shown a decrease of about 10 recalls per year during the 11-year period of analysis. Conclusion: Devices approved through the 510(k) process, compared with the PMA process, were more likely to be recalled for design defects. Although device design is the most common reason for device recall, many recalls are due to suboptimally standardized processes (e.g., packaging, process controls, device labeling). Overall, orthopedic hip device recalls decreased during the period of analysis (2007–17).

Lifecycle evaluation of medical devices: supporting or jeopardizing patient outcomes? A comparative analysis of evaluation models

“…Whilst post-market surveillance is designed to detect only the most severe adverse outcomes, which are just a fraction of adverse outcomes that matter to patients (3;39). Furthermore, clinicians and patients are not readily made aware of evidence regarding a device's poor safety record, as demonstrated by Peters, Pellerin, and Janney, whose study showed that recalls of Class III devices in the US took more than 8 months to complete (40). Several authors have also demonstrated that although a device has been recalled it may still be used as a predicate (i.e., a substantially equivalent, legally marketed) device to support the market authorization of many subsequent devices through equivalence claims (38;41-44).…”