Published 7/28/2026
The Food and Drug Administration (FDA) has issued an updated safety communication regarding the Hintermann Series H3 Total Ankle Replacement (TAR) System, citing a higher-than-expected risk of device failure based on an ongoing data review.
The June 3 update alerts patients, caregivers, and healthcare providers to concerns including elevated long-term failure rates, an increased likelihood of revision surgery, and reports of polyethylene (plastic) component fracture associated with the device. The H3 TAR system, manufactured by DT MedTech LLC, has been evaluated through multiple sources, including mandated post-market studies, published literature, registry data, and adverse event reports.
In light of these findings, the FDA recommends that clinicians consider alternative treatment options when appropriate and engage patients in shared decision-making regarding available surgical choices, including ankle fusion and other ankle replacement systems. For patients who currently have the device implanted, the FDA does not advise preventive removal if the implant is functioning well and the patient remains asymptomatic. Continued routine follow-up and monitoring for new or worsening symptoms, such as pain, instability, or difficulty bearing weight,are encouraged.
The agency emphasizes that it is continuing to evaluate data related to the device and may update its recommendations as additional information becomes available. Clinicians are also encouraged to report adverse events to support ongoing safety monitoring.
This communication is intended to support awareness and informed conversations between patients and providers regarding total ankle replacement options and associated risks.