In a recent alert, the U.S. Food and Drug Administration (FDA) has raised concerns about a higher-than-expected risk of device failure associated with the Hintermann Series H3 Total Ankle Replacement (TAR) system, manufactured by DT MedTech LLC.

The FDA said that its evaluation of interim post-approval study (PAS) results for the Hintermann Series H3 TAR system, along with real-world data, indicates a heightened risk of failure. Specifically, the results suggest a significant increase in the rate of additional surgery (removals or revisions of metal components) at 16.1%, compared to the premarket clinical studies rate of 9.9%. When considering all types of revisions, including those of the plastic component, the rate of additional surgery rises to at least 28.5%.

The FDA further communicated that it is actively collaborating with the company to analyse data from various sources, aiming to comprehend the potential causes behind this elevated failure rate.

In its alert, the US Drug Regulator advised patients currently considering the Hintermann Series H3 TAR system to discuss treatment options for painful arthritic ankle joints with their healthcare providers.

Pointing out that it is crucial to understand the benefits and risks associated with joint replacement medical devices and procedures, the Drug Regulator stated that it recommends against surgery if the Hintermann Series H3 TAR system is functioning well and there is no new or worsening pain or symptoms.

FDA advises people experiencing new or worsening pain, swelling, difficulty using the ankle, weight loss, grinding noise, or weakness around the implanted device to consult a healthcare provider promptly.

The Drug Regulator urged healthcare providers to review and discuss the recommendations for patients and carers with their patients. Shared decision-making is essential, involving a comprehensive discussion of the benefits and risks of all relevant treatment options for painful arthritic ankle joints. Given the higher risk of device failure associated with the Hintermann Series H3 TAR system, careful adherence to the Instructions for Use is crucial, as advised.