| Autor: |
Michael J. Radcliffe, DPM, Thomas S. Roukis, DPM, PhD, FACFAS |
| Jazyk: |
angličtina |
| Rok vydání: |
2024 |
| Předmět: |
|
| Zdroj: |
Foot & Ankle Surgery: Techniques, Reports & Cases, Vol 4, Iss 1, Pp 100356- (2024) |
| Druh dokumentu: |
article |
| ISSN: |
2667-3967 |
| DOI: |
10.1016/j.fastrc.2023.100356 |
| Popis: |
Background: The Cartiva® Synthetic Cartilage Implant has been available in the United States since 2016. Despite promising early results in the treatment of first metatarsophalangeal joint osteoarthritis, literature reporting higher-than-anticipated rates of adverse events and catastrophic failure soon followed its widespread use. The purpose of this manuscript is to review all adverse events submitted for this device into the Manufacturer and User Facility Device Experience database. Methods: The Manufacturer and User Facility Device Experience database was retrospectively reviewed between July 2016 and June 2023 for adverse events related to the Cartiva® Synthetic Cartilage Implant. Non-first metatarsophalangeal joint usage, duplicate submissions, and literature review reports were excluded. Results: A total of 236 unique submissions were identified. The most common Device Problem was an Unspecified Device Issue (N=129, 55%). The most common Patient Problem identified was Pain/Inflammation (N=133, 56%). Implant removal occurred in 73.7% with an additional 9.3% pending removal. Of the 102 revision surgeries, 67.7% were converted to fusion. Conclusion: Analysis of the Manufacturer and User Facility Device Experience database submissions demonstrates that the Cartiva® Synthetic Cartilage Implant has continued dysfunction issues yet remains on the market. It represents the unfortunately repetitive rise and fall of new surgical devices accepted too early in the usage life cycle before mid- to -long-term outcomes exist. This raises questions about the utility of this database and about transparency by surgical device companies regarding their reported patient benefit-to-risk ratios. Based on our findings, we propose a restructuring of the Manufacturer and User Facility Device Experience database reporting rules. Level of evidence: IV, Case series from large database analysis Classification: Forefoot reconstruction |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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