Devices

Safety Data Update on Hintermann Ankle Device

FDA has issued an updated safety communication confirming long-term post-approval data showing that the Hintermann Series H3 Total Ankle Replacement system continues to demonstrate a higher-than-expected risk of device failure, with revision rates increasing significantly over 10 years of follow-up.

According to a final post-approval study (PAS) report submitted by manufacturer DT MedTech LLC, the estimated probability of additional surgery to remove or revise metal components was 14.9% at 10 years, more than double the 6.5% rate at five years. When revisions of all components — including polyethylene — were counted, the estimated 10-year rate rose to 31.8%, up from 19.2% at five years.

The agency says the updated figures are based on long-term follow-up of patients originally enrolled in the device’s premarket clinical studies and reflect statistical modeling of time-to-revision data. The agency adds that its recommendations to patients and providers remain unchanged from those first issued 2/2024, when the initial alert was released.

“The FDA continues to work with the manufacturer to evaluate all available information about the performance of Hintermann Series H3 TAR systems and the risk of device failure,” the agency says, adding that it will “ensure that patients and providers are aware of the PAS data on the long-term risk of device failure.”

Additionally, FDA is urging orthopedic surgeons to discuss the potential for device failure and revision surgery with current and prospective H3 TAR patients and to report adverse events through the MedWatch system.

The Hintermann Series H3 Total Ankle Replacement, cleared for use in patients requiring ankle joint replacement due to severe arthritis or injury, came on the market based on clinical data showing lower failure rates.

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