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

Introduction The 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. Methods The 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. Results Out 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. Conclusions A 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.

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Copyright © 2020, Pellerin et al.

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The views expressed in this article are those of the author(s) and do not necessarily reflect the official policy or position of the Department of the Navy, Department of Defense, or the United States Government. LCDR Cory Janney is a military service member (or employee of the U.S. Government). This work was prepared as part of their official duties. Title 17, USC, §105 provides that ‘Copyright protection under this title is not available for any work of the U.S. Government.’ Title 17, §101 defines a U.S. Government work as a work prepared by a military service member or employee of the U.S. Government as part of that person’s official duties.