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Biomet titanium mandible implants

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Hazard alert - potential for component fracture

22 October 2014

Consumers and health professionals are advised that Biomet Australia, in consultation with the TGA, is issuing a hazard alert for its titanium mandible implants due to the potential risk of fatigue fractures in two batches.

A titanium mandible implant replaces part of the jawbone. It is used to correct congenital deficiencies or defects resulting from trauma.

It has been identified that there is a potential risk of the implant fracturing due to a manufacturing fault. If an implant fractured it is highly likely that jaw function will be compromised, and device replacement will be required. The potential fracture sites are circled in the accompanying images of a Narrow TI Mandible Implant (left) and Standard TI Mandible Implant (right).

Titanium mandible implants

The potential issue was identified during company testing and Biomet Australia advises that worldwide it has not received any reports of an affected implant fracturing in a patient.

The two batches affected by this issue are 525190A and 525190B.

Information for consumers

Biomet Australia has written to surgeons who have implanted its titanium mandible implants, and hospitals where these operations were performed, providing further information about this issue, including advice on how to treat affected patients.

If you or someone you care for has a Biomet Australia titanium mandible implant and you have any questions or concerns about this issue, contact your health professional or the hospital where the operation was performed.

Information for all health professionals

If you are treating a patient who has had a Biomet Australia titanium mandible implant, and they or their caregivers have any questions or concerns about the above issue, refer them to their managing surgeon or the hospital where the operation was performed.

Advise them that, if they experience any unusual symptoms such as pain or breathing difficulties or symptoms suggestive of a fractured mandible, to promptly contact their managing surgeon or the hospital where the operation was performed.

Information for orthopaedic surgeons

Biomet Australia advises that if the implant does not fracture following implantation, the risks of a revision surgery may outweigh the benefits of device removal.

Provided that the patient remains asymptomatic, and there is no fracture of the condylar neck, removing the implant could result in unnecessary soft tissue and nerve damage. If however, the implant does fracture, it is likely that jaw function would be negatively impacted, and a device replacement would be required. Such risks for a revision surgery would be similar to other revision surgeries where there is a device failure.

Reporting problems

Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).

The TGA cannot give personal 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.