Zimmer Biomet, a global manufacturer of orthopaedic prosthetic components, has issued an urgent recall notice for a component part of its comprehensive reverse shoulder replacement system; the comprehensive humeral tray.
The shoulder joint is a ball and socket-type joint made up of the humerus (the arm bone, which forms the ball of the joint) and the glenoid (which forms the socket). When a shoulder becomes injured, for example following significant rotator cuff tear, the humeral head begins to move out of the socket. This causes wearing of the joint surfaces, resulting in arthritis. Arthritis can affect the shoulder joint by restricting the patient’s arm and shoulder movement and causing the patient pain. In such situations, a replacement of the joint may be necessary.
Traditionally, the shoulder joint was replaced with artificial components like for like. A more contemporary approach is to reverse the anatomy of the joint. During a reverse shoulder replacement, the relationship between the ball and the socket are reversed (the humeral head becomes the socket and the glenoid socket is replaced with a ball). This enables the shoulder to function without the rotator cuff and the stronger muscles around the shoulder joint to move the arm with less force, improving on the range of movement that would be achieved with a traditional replacement.
The reason for Zimmer Biomet’s urgent recall is stated to be greater than expected fracture rates in certain components, causing patients to require revision procedures that might otherwise have been avoided. The recall is specific to certain components manufactured between August 2008 and September 2011, and implanted between October 2008 and May 2015. The full notice, including details of the specific components recalled, can be found here. Hospitals and surgeons have been notified.
Arran Macleod, an associate in the product liability team at Penningtons Manches, said: "Reverse shoulder replacement surgery is a relatively new procedure and is not without risk of complication. However, failure of the shoulder replacement should not occur as a result of a component that appears to be more easily fractured than it should be.
“Zimmer Biomet’s recall notice is only for certain batches of components, so it will not affect all patients fitted with the reverse shoulder replacement system. However, we recommend anyone who has had a Zimmer Biomet reverse shoulder replacement, and who has experienced problems, to contact their GP or treating surgeon."