FDA Recommends Alternatives to Hintermann Ankle Replacement System Due to Failure Risks

The U.S. Food and Drug Administration (FDA) has updated its safety communication regarding the Hintermann Series H3 Total Ankle Replacement (TAR) System, advising patients, caregivers, and healthcare providers to consider alternative treatment options. This recommendation comes due to observed elevated long-term risks associated with the device, manufactured by DT MedTech LLC.

The FDA's assessment highlights a higher-than-expected risk of device failure and revision surgery for the Hintermann Series H3 TAR System. Additionally, there is a noted risk of polyethylene fracture, which refers to the breakage of the plastic components within the device.

The agency continues to monitor the device's performance by reviewing data from mandated postmarket studies, scientific literature, and various real-world sources. These sources include registry data, adverse event reports, and information provided directly by the manufacturer.