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 (TAR) system due to a higher-than-expected risk of device failure. The communication provides specific recommendations for patients currently implanted with the device or considering it, as well as for their healthcare providers.
Manufacturers of total ankle replacement systems, specifically DT MedTech, LLC, as well as orthopedic surgeons, hospital risk managers, and regulatory compliance teams overseeing implantable orthopedic devices.
This update signals a significant safety concern regarding the long-term durability of the Hintermann H3 system. From a regulatory perspective, this suggests that the FDA has identified a trend in clinical performance data that deviates from original pre-market expectations. Impacted firms may face increased scrutiny regarding their post-market data collection and may need to evaluate if current labeling or instructions for use sufficiently address these elevated failure risks.
Review existing post-market surveillance data for the Hintermann Series H3 system and update Risk Management Files to reflect the increased device failure rate. Ensure medical communication teams are equipped with the updated FDA safety recommendations for patient and provider outreach. Document all internal assessments regarding the clinical performance of these implants.
Learn more about recommendations for patients who are considering a Hintermann Series H3 TAR system or who have one; recommendations for health care providers.
Open in openFDA / FDA.gov