Analysis of Polyethylene-Related Revisions After Total Ankle Replacements Reported in US Food and Drug Administration Medical Device Adverse Event Database. (January 2023)

• Record Type: Journal Article
• Authors: Jiang, Hongying; Wu, Leihong; Randsborg, Per-Henrik; Houck, Jennifer; Sun, Limin; Marine, Marissa; Chow, Megan; Peluso, Joseph; Peat, Raquel
• Is Part Of: Foot & ankle international. Volume 44:Number 1(2023)
• Page Start: 13
• Page End: 20
• Publication Date: 2023-01
• Subjects: total ankle replacement -- TAR -- adverse event -- revision -- polyethylene-related adverse events -- polyethylene fractures -- polyethylene wear -- FDA -- FDA Manufacturer and User Facility Device Experience -- MAUDE -- MDR -- ultrahigh molecular weight polyethylene -- UHMWPE; Foot -- Abnormalities -- Periodicals; Ankle -- Abnormalities -- Periodicals; Orthopedics -- Periodicals; 617.585
• DOI: 10.1177/10711007221134284
• Languages: English
• ISSNs: 1071-1007

Abstract

Background: There are 2 general types of total ankle replacement (TAR) designs with respect to the polyethylene insert, mobile-bearing (MB) and fixed-bearing (FB) TARs. The aim of this study is to compare polyethylene-related adverse events (AEs), particularly revisions, reported for MB TARs and FB TARs using the US Food and Drug Administration's (FDA's) Manufacturer and User Facility Device Experience (MAUDE) database. Methods: A text mining method was applied to the medical device reporting (MDR) in the MAUDE database from 1991 to 2020, followed by manual reviews to identify, characterize, and describe all polyethylene-related AEs, including revisions, reported for MB and FB TARs. Results: We found 1841 MDRs for MB (STAR Ankle only) and 1273 MDRs for 40+ FB TARs approved/cleared by the FDA. For the MB design, 33% (606/1841) of the AEs reported related to the polyethylene component, compared to 24% (291/1273) of the AEs reported for FB designs. Polyethylene fractures were reported in 11.3% (208/1841) for the MB designs compared to 0.2% (2/1273) for the FB designs. Half of the polyethylene-related revisions occurred within an average of 4.1 years after implantation for the MB design compared within an average of 5.2 years for FB designs. Conclusion: Analysis of this database revealed a higher proportion of reported polyethylene fractures and greater need for earlier revisions for polyethylene-related issues with use of the primary MB design in the database as compared with FB TAR designs. Further study of device-related complications with more recent designs for both MB and FB ankle replacement components are needed to improve the outcomes of total ankle replacement. Level of Evidence: Level III, retrospective comparative study.