Affinis Fracture ceramic head (used in shoulder replacements)

Consumers and health professionals are advised that Mathys Orthopaedics, in consultation with the TGA, has issued a hazard alert for its Affinis Fracture ceramic head. Mathys Orthopaedics has also initiated a recall for product correction to update the Instructions for Use (IFU) and Surgical Technique documents.

Affinis Fracture ceramic head is a component of an implant used in shoulder replacement surgeries. It replaces the humeral head in the shoulder joint.

It has been identified that there is a risk of disconnection of components of the implant from each other due to inadequate fixation during surgery. The risk is being reduced by updating the IFU and Surgical Technique documents to provide surgeons clear instructions for the procedure associated with this particular device.

If a disconnection occurs, the patient may experience pain and/or loss of function and will require revision surgery to correct the problem.

Mathys Orthopaedics is undertaking the same recall actions for its Affinis Inverse inlays ceramys, but this device has not been supplied in Australia.

Information for consumers

Mathys Orthopaedics has written to orthopaedic surgeons who have implanted Affinis Fracture ceramic heads providing further information about this issue.

If you have had a shoulder replacement and experience unexpected pain in your shoulder or loss of function, or if you have any questions or concerns about the above issue, you should contact your surgeon or the hospital where the surgery was performed.

Information for all health professionals

Mathys Orthopaedics has written to orthopaedic surgeons who have implanted Affinis Fracture ceramic heads providing further information about this issue.

If you are treating a patient who has had a shoulder replacement and they present with unexpected pain or loss of function, of if they have any questions or concerns about this issue, refer them to their surgeon or to the hospital where the surgery was performed.

Information for orthopaedic surgeons

Mathys Orthopaedics has received post-market notifications of disconnections of Affinis Fracture ceramic heads.

Investigations revealed that the disconnections may have resulted from inadequate primary fixation due to insufficient head-cone connection or by protruding bone residue, cement residue or soft tissue fragments inside the cone connection.

When implanting an Affinis Fracture ceramic head, it is recommended that you:

• clean and dry the stem component
• remove any protruding bone and soft tissue fragments
• mount the ceramic head onto the cone with a positive fit by applying rotation and axial pressure
• place the head impactor on the pole of the ceramic head and, with a gentle stroke of the hammer in axial direction on the head impactor, fixate the ceramic head firmly on the bone.

These recommendations and other instructions have been added to the IFU and Surgical Technique. You should replace all IFU and Surgical Technique documents with the up-to-date versions in your hospital or practice.

If you have any questions or concerns regarding this issue, contact Mathys Orthopaedics on 02 9417 9200.

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 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.