Category: Medicine · Supplier: Unknown
Recall date: 12 February 2026
The TGA has concerns about an increased risk of revision as shown in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) data when compared to other fixed and mobile bearing systems.
If you have an implanted H3 Hintermann Ankle Replacement System, you may be at higher risk of requiring additional surgery. Symptoms of device failure may include: Any new or worsening pain or swellingInability to use your ankle or bear weightGrinding or other noiseWeakness in the ankle around the implanted device Surgical removal is not recommended if the implant is functioning well and you have no new or worsening pain. What should patients do? Contact your surgeon or health care provider if you have a H3 Hintermann Ankle Replacement System implanted, and you experience any of the symptoms mentioned in the ‘What are the risks’ section above. What should health professionals do? Quarantine all un-implanted stock in your possession until further notice.Monitor patients implanted with the Hintermann Series H3 TAR system for device problems, including development of symptoms in the “what are the risks” section above.Consider treatment options if loosening and fractures of the affected implant components are observedFor suspected issues, consider performing X-rays to further evaluate Device integrity.Discuss the benefits and risks of all relevant treatment options for painful arthritic ankle joints with patients.
Explore more medicine recalls or run a broader search across all sources.