Devices

Safety Alert on Hintermann Ankle Replacement

FDA has issued a safety alert on a higher-than-expected risk of device failure with DT MedTech’s Hintermann Series H3 Total Ankle Replacement (TAR) system. The agency says it is evaluating interim post-approval study (PAS) results on the device and other real-world data.

“For patients with the Hintermann Series H3 TAR system, the results suggest a higher rate of failure, specifically, additional surgery (removals or revisions of metal components, at least 16.1%) associated with the implanted device compared with the rate in the premarket clinical studies (9.9%),” the alert says. If all types of revisions are included in PAS results (such as revisions of the plastic component as well as the metal component), the rate of additional surgery is at least 28.5%, it adds.

Additionally, FDA says it is working with the company to evaluate data from all available sources to better understand the issue.

Safety Alert on Hintermann Ankle Replacement

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