Analysis of 408 Total Ankle Arthroplasty Adverse Events Reported to the US Food and Drug Administration From 2015 to 2018

Abstract

Background. Total ankle arthroplasty (TAA) use has increased with newer generation implants. Current reports in the literature regarding complications use data extracted from high-volume centers. The types of complications experienced by lower-volume centers may not be reflected in these reports. The purpose of this study was to determine a comprehensive TAA adverse event profile from a mandatory-reporting regulatory database. Methods. The US Food and Drug Administration’s Manufacturer and User Facility Device Experience (MAUDE) database was reviewed from 2015 to 2018 to determine reported adverse events for approved implants. Results. Among 408 unique TAA device failures, the most common modes of failure were component loosening (17.9%), intraoperative guide or jig error (15.4%), infection (13.7%), and cyst formation (12.7%). In addition, the percentage distribution of adverse event failure types differed among implants. Conclusion. The MAUDE database is a publicly available method that requires mandatory reporting of approved device adverse events. Using this report, we found general agreement in types of complications reported in the literature, although there were some differences, as well as differences between implants. These data may more accurately reflect a comprehensive profile of TAA complications as data were taken from a database of all device users rather than only high-volume centers.

Levels of Evidence: NA