The FDA has issued an alert on higher-than-expected device failure rates with the Hintermann Series H3 Total Ankle Replacement system, manufactured by DT MedTech.
The rate of additional surgery for patients with the Hintermann system is at least 28.5%, according to a Feb. 29 FDA alert.
Patients require a removal or revision of the Hintermann metal components in at least 16.1% of cases, compared to 9.9% of patients in the premarket clinical studies.
The FDA is reviewing all clinical and premarket data and working with the manufacturer to evaluate, according to the alert.
The FDA recommends that any patients with a Hintermann system experiencing pain, inability to bear weight, grinding or weakness around the implanted device contact their surgeon and report any complications to the FDA.