Mathys Orthopaedics, in association with the Therapeutic Goods Administration of Australia, has issued a hazard alert for the Affinis Fracture ceramic head, which is used in shoulder replacements.
In addition, Mathys Orthopaedics has issued a recall for product correction to update the Instructions for Use (IFU) and the Surgical Technique documents associated with the implant, according to a document from the Therapeutic Goods Administration (TGA) of the Australian Government Department of Health.
In the document, the Affinis Fracture ceramic head, which replaces the humeral head in the shoulder joint, was identified as associated with a risk of the components of the implant disconnecting from each other due to inadequate fixation during surgery. The company noted it is reducing the risk through updated Instructions for Use (IFU) and Surgical Technique documents that provide surgeons with clear instructions for the procedure used with this implant.
If a disconnection occurs, a patient with the Affinis Fracture ceramic head may experience loss of function and/or pain. Mathys Orthopaedics representatives reported a patient will require revision surgery to correct the problem.
Mathys Orthopaedics noted it has sent written warning to orthopaedic surgeons who have implanted Affinis Fracture ceramic heads and told them a patient with the implant who has unexpected pain or loss of function after shoulder replacement surgery should be referred to their surgeon or to the hospital where the surgery was performed.
Mathys Orthopaedics added recommendations to the Affinis Fracture ceramic head IFU and Surgical Technique, which include cleaning and drying the stem component, removing any protruding bone and soft tissue fragments and mounting the ceramic head onto the cone with a positive fit by applied rotation and axial pressure.