UPDATE: Hintermann Series H3 Total Ankle Replacement Has a Higher-Than-Expected Risk of Device Failure: FDA Safety Communication
The FDA issued an updated safety communication regarding the Hintermann Series H3 Total Ankle Replacement, noting a higher-than-expected risk of device failure.
This affects DT MedTech, LLC, orthopedic surgeons, surgical facilities, and regulatory or clinical compliance professionals responsible for orthopedic implant monitoring.
The higher-than-expected failure rate suggests that existing clinical data or pre-market assumptions may no longer align with post-market performance. For regulatory teams, this likely necessitates an urgent review of post-market clinical follow-up (PMCF) data and potential adjustments to the benefit-risk profile for the device. The update indicates a persistent or escalating safety signal that may lead to further regulatory restrictive actions if revision rates do not stabilize.
Verify that post-market surveillance systems are capturing long-term revision rates for this specific device. Update risk management files and clinical evaluation reports to reflect the higher-than-expected failure risk. Ensure clinical teams are monitoring implanted patients for signs of device failure or the need for revision surgery.
FDA Medical Device Safety Communication: UPDATE: Hintermann Series H3 Total Ankle Replacement Has a Higher-Than-Expected Risk of Device Failure: FDA Safety Communication. Joint Replacement. Source: https://www.fda.gov/medical-devices/safety-communications/update-hintermann-series-h3-total-ankle-replacement-has-higher-expected-risk-device-failure-fda
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