FDA Warns on Additional Surgeries for Ankle Replacement System

The FDA is alerting artificial ankle patients, their providers and caregivers about safety concerns regarding the Hintermann Series H3 Total Ankle Replacement (TAR) system and working with the Baltimore-based manufacturer — DT MedTech — to investigate failure causes.

TAR systems provide a total ankle prosthesis consisting of a metal plate in the lower leg, a metal ankle component and a mobile plastic component. In evaluating results of an interim post-approval study, the agency found failure rates leading to additional surgery that surpassed 28 percent.

The agency suggests patients with the Hintermann Series H3 TAR system contact their health care provider if experiencing discomfort, weakness around the device or grinding noises. Providers should consider the higher risk of device failure — compared with the rate in premarket clinical studies — when considering a recommendation of the system.

Read the FDA Safety Communication here.

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