On Feb. 29, the U.S. Food and Drug Administration (FDA) is alerting patients, caregivers, and healthcare providers about a higher-than-expected risk of device failure with the Hintermann Series H3 Total Ankle Replacement (TAR) system, manufactured by DT MedTech LLC.
The FDA is evaluating interim post-approval study (PAS) results for the Hintermann Series H3 TAR system 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%). When all types of revisions are included in the interim 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%.
The FDA is working with the manufacturer to evaluate data from all available sources to better understand potential causes of the higher failure rate.
FDA has the full alert.
