On December 20, 2016, Zimmer Biomet sent an Urgent Medical Device Recall Notice to health care providers who used the Comprehensive Reverse Shoulder Device. Patients who received total shoulder replacements using the device were also notified.
The U.S. Food and Drug Administration (FDA) has identified the notice as a Class I recall. This is the most serious type of recall issued by the agency. The use of the affected devices may cause serious injuries or death.
What is a Reverse Shoulder Device?
A conventional shoulder replacement device mimics the normal anatomy of the shoulder. A plastic cup is fitted into the shoulder socket and a metal ball is attached to the top of the upper arm bone. A reverse should device, otherwise called a reverse total shoulder replacement (RTSA), the socket and metal ball are switched. The metal ball is fixed to the socket and the plastic cup is fixed to the upper end of the humerus.
A reverse total shoulder replacement is more effective for patients with cuff tear arthropathy because it relies on different muscles to move the arm. In a patient with a large rotator cuff tear and cuff tear arthropathy, a reverse total shoulder replacement relies on the deltoid muscle, instead of the rotator cuff, to power and position the arm.
Complications Associated with RTSA
Complication rates after reverse total shoulder arthroplasty are three to five times that of conventional total shoulder replacement arthroplasty. This is according to a study published in the journal Current Reviews in Musculoskeletal Medicine.
The complications described in the study included:
- Neurological injury
- Infection
- Dislocation
- Instability
- Acromial or scapular spine fracture
- Hematoma
- Scapular notching
Despite the benefits of the RTSA, patients who undergo this procedure are often subject to complications similar to conventional total shoulder arthroplasty as well as unique to RTSA because of the major anatomical, physiological, and bio-mechanical changes made to the shoulder joint.
Patients wondering if the Reverse Shoulder Device recall applies to them, may find this article helpful.