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

Abstract

Category: Ankle Arthritis Introduction/Purpose: 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 less experienced 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 2015-2018 to determine reported adverse events for approved implants. We recorded the type of adverse event and excluded duplicate reports and those extracted from already published literature. We categorized the adverse events into infection, intraoperative guide/jig error, component loosening (tibia or talus), cyst formation, component fracture, gutter impingement/heterotopic ossification, iatrogenic fracture, polyethylene wear, component dissociation, malalignment, malalignment recurrence, direct surgeon error, and miscellaneous. The overall percentage distribution of each of the adverse events failure causes was calculated as was the percentage distribution for each total ankle device. Results: Among 408 unique TAA device failures, the modes of failure listed by commonality were component loosening (17.9% [9.6% tibia, 8.3% talus]), intraoperative guide or jig error (15.4%), infection (13.7%), cyst formation (12.7%), gutter impingement/heterotopic ossification (10.3%), component fracture (9.6%), iatrogenic fracture (5.4%), poly wear (3.7%), component dissociation (3.2%), malalignment (2.5%), miscellaneous (2.9%), malalignment recurrence (2.2%), and direct surgeon error (0.5%). These were consistent with some systematic reviews of the literature but in disagreement with others which found high rates of iatrogenic fracture. In addition, the percentage distribution of adverse event failure types differed among implants. Conclusion: The MAUDE database is a publicly available method which 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. In addition, intraoperative guide or jig errors were very common and may not have been previously appreciated. This data may more accurately reflect a comprehensive profile of TAA complications as data was taken from a database of all device users rather than only high-volume centers.