Practical implication
Not assessed
Based on post-approval study and registry data, the FDA warns of a 31.8% revision rate at 10 years, significantly higher than the 2% expectation. The Australian TGA has prohibited sale/distribution as of May 5, 2026. The FDA recommends considering alternative treatments where possible and continued monitoring.
What changed: FDA updated its safety communication to reflect new long-term data showing a 31.8% revision rate at 10 years and a polyethylene fracture risk four times higher than other devices, leading to recommendation to consider other treatment options and publication of UDI information.
Why it matters: The device shows a substantially higher failure rate than expected, with potential for serious patient harm including need for revision surgery and device fracture. Regulatory actions in Australia (sales ban) underscore the severity.
Practical implication: Patients with H3 TAR should contact their surgeon if experiencing new/worsening pain. Healthcare providers should monitor closely for signs of failure, consider alternative treatments for new patients, and report adverse events via MedWatch.
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Published from the Firecrawl agent regulatory extraction pipeline.
