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Actis Medical Pty Ltd is:
- Quarantining all un-implanted units of the H3 Hintermann Ankle Replacement System, manufactured by DT MedTech LLC; and
- Alerting patients, caregivers, and health care providers about an increased risk of revision for this system.
What is the problem?
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.
The affected devices from the H3 Hintermann Ankle Replacement System include:
- ARTG number 289319: Actis Medical Pty Ltd - Ankle prosthesis bearing
- ARTG number 289321: Actis Medical Pty Ltd - Coated ankle talus prosthesis and
- ARTG number 289424: Actis Medical Pty Ltd - Coated ankle tibia prosthesis
What are the risks?
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 swelling
- Inability to use your ankle or bear weight
- Grinding or other noise
- Weakness 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 observed
- For 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.
Reporting problems
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to our monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.