PMID- 36461676 OWN - NLM STAT- MEDLINE DCOM- 20230110 LR - 20230117 IS - 1944-7876 (Electronic) IS - 1071-1007 (Linking) VI - 44 IP - 1 DP - 2023 Jan TI - Analysis of Polyethylene-Related Revisions After Total Ankle Replacements Reported in US Food and Drug Administration Medical Device Adverse Event Database. PG - 13-20 LID - 10.1177/10711007221134284 [doi] AB - 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. FAU - Jiang, Hongying AU - Jiang H AUID- ORCID: 0000-0001-8866-0254 AD - Office of Product Evaluation and Quality at the Center for Devices and Radiological Health, US Food and Drug Administration (FDA), Silver Spring, MD, USA. FAU - Wu, Leihong AU - Wu L AD - Division of Bioinformatics and Biostatistics, National Center for Toxicological Research, FDA, Jefferson, AR, USA. FAU - Randsborg, Per-Henrik AU - Randsborg PH AUID- ORCID: 0000-0002-7674-1572 AD - Department of Orthopaedic Surgery, Akershus University Hospital, Norway. FAU - Houck, Jennifer AU - Houck J AD - Office of Product Evaluation and Quality at the Center for Devices and Radiological Health, US Food and Drug Administration (FDA), Silver Spring, MD, USA. FAU - Sun, Limin AU - Sun L AD - Office of Product Evaluation and Quality at the Center for Devices and Radiological Health, US Food and Drug Administration (FDA), Silver Spring, MD, USA. FAU - Marine, Marissa AU - Marine M AD - Office of Product Evaluation and Quality at the Center for Devices and Radiological Health, US Food and Drug Administration (FDA), Silver Spring, MD, USA. FAU - Chow, Megan AU - Chow M AD - Office of Product Evaluation and Quality at the Center for Devices and Radiological Health, US Food and Drug Administration (FDA), Silver Spring, MD, USA. FAU - Peluso, Joseph AU - Peluso J AUID- ORCID: 0000-0002-7133-0731 AD - Office of Product Evaluation and Quality at the Center for Devices and Radiological Health, US Food and Drug Administration (FDA), Silver Spring, MD, USA. FAU - Peat, Raquel AU - Peat R AD - Office of Product Evaluation and Quality at the Center for Devices and Radiological Health, US Food and Drug Administration (FDA), Silver Spring, MD, USA. LA - eng PT - Journal Article DEP - 20221202 PL - United States TA - Foot Ankle Int JT - Foot & ankle international JID - 9433869 RN - 9002-88-4 (Polyethylene) SB - IM MH - United States MH - Humans MH - *Arthroplasty, Replacement, Ankle/adverse effects MH - Polyethylene MH - United States Food and Drug Administration MH - Retrospective Studies MH - Ankle Joint/surgery MH - Databases, Factual OTO - NOTNLM OT - FDA OT - FDA Manufacturer and User Facility Device Experience OT - MAUDE OT - MDR OT - TAR OT - UHMWPE OT - adverse event OT - polyethylene fractures OT - polyethylene wear OT - polyethylene-related adverse events OT - revision OT - total ankle replacement OT - ultrahigh molecular weight polyethylene EDAT- 2022/12/04 06:00 MHDA- 2023/01/11 06:00 CRDT- 2022/12/03 02:53 PHST- 2022/12/04 06:00 [pubmed] PHST- 2023/01/11 06:00 [medline] PHST- 2022/12/03 02:53 [entrez] AID - 10.1177/10711007221134284 [doi] PST - ppublish SO - Foot Ankle Int. 2023 Jan;44(1):13-20. doi: 10.1177/10711007221134284. Epub 2022 Dec 2.