Recall Rates of Total Knee Arthroplasty Devices Are Dependent on the FDA Approval Process.

Abstract

IntroductionThe medical device industry has grown substantially in recent years. There is limited research examining orthopedic subspecialties and the recall of orthopedic devices. We hypothesize that knee arthroplasty devices cleared through the Food and Drug Administration (FDA) 510(k)-notification process would have a higher recall rate than the premarket approval (PMA) process.MethodsThe FDA database was thoroughly queried for all knee arthroplasty surgical devices from January 1, 2007 through December 31, 2017. Recalled devices were analyzed by manufacturer, type of implant, recall class, manufacturer-determined reason, FDA-determined reason, quantity affected, submission type, and distribution within the United States or internationally.ResultsOut of over 30,000 medical devices on the market, a total of 300 knee arthroplasty devices from 18 different companies were recalled during the time frame of this study. Tibial components accounted for 35.33% of devices, polyethylene implants for 38.67%, and femoral components for 15%. The most common reason for recall was device design (n = 134, 44.67%), followed by process control (n = 32, 10.67%). Of the 300 knee arthroplasty devices recalled, 267 (89.0%) were cleared through the 510(k) premarket notification process and 33 (11.0%) devices were approved through the PMA process.ConclusionsA larger proportion of knee arthroplasty surgical devices cleared through the 510(k) process were recalled compared to implants approved through the stricter PMA process. Changing the 510(k) process may enable manufacturers to improve upon the safety of their devices.