Adverse events related to total ankle replacement devices: an analysis of reports to the United States Food and Drug Administration.
Publication/Presentation Date
9-1-2021
Abstract
BACKGROUND: The published outcomes of total ankle replacement (TAR) implants came from limited institutions creating observational bias. For broader perspective, we queried the Food and Drug Administration's (FDA) Manufacturer and User Facility Device Experience (MAUDE) voluntary database to explore complications reported outside published literature.
METHODS: The database was reviewed retrospectively between November 2011 and April 2019 using two product codes assigned to six TAR devices.
RESULTS: Among 648 relevant reports available in the database, common complications were aseptic loosening (19.3%), infection (18.2%), and alignment/mechanical issues (16.5%). Others included instrument/instrumentation complications, impingement, polyethylene problems, fractures, avascular necrosis of talus (AVN), and packaging issues.
CONCLUSION: MAUDE database revealed various patterns of device-related malfunctions that have been under-reported in published data. Despite inconsistency in the available reports, it provided opportunities for improvements in quality control, device design, and ultimately patient safety. Database would be further strengthened by more robust reporting mechanism or mandatory reporting of device-related complications.
Volume
45
Issue
9
First Page
2307
Last Page
2312
ISSN
1432-5195
Published In/Presented At
Mahmoud, K., Metikala, S., O'Connor, K. M., & Farber, D. C. (2021). Adverse events related to total ankle replacement devices: an analysis of reports to the United States Food and Drug Administration. International orthopaedics, 45(9), 2307–2312. https://doi.org/10.1007/s00264-021-04972-z
Disciplines
Medicine and Health Sciences
PubMedID
33575857
Department(s)
Department of Surgery
Document Type
Article
