Zimmer Biomet’s reverse shoulder implant is geared towards individuals with severe shoulder arthritis or a torn rotator cuff. It’s marketed as a device for patients that have found traditional joint-replacement options unsuccessful.
Recall for the Comprehensive Reverse Shoulder Humeral
In 2017, the U.S. Food and Drug Administration issued a recall for this medical device, also known as the Comprehensive Reverse Shoulder Humeral. The implants, the agency was alerted by Zimmer Biomet, were fracturing at a higher rate than usual.
The recall is classified as a Class I recall, the most severe type the FDA issues, indicating that use of the device “may cause serious injury or death.” The recall affects more than 3,000 devices and patients.
How the Zimmer Biomet Reverse Shoulder Implant Works
For some patients — particularly those suffering from a type of arthritis called cuff-tear arthropathy — traditional shoulder replacement is not an option. Their rotator cuff will not accommodate it. Such surgery would come with the risks of limited motion and pain thereafter.
For these patients, there is the option of a reverse total shoulder replacement. This type of shoulder replacement uses the deltoid muscle, instead of the rotator cuff, to move and position the arm.
Zimmer Biomet’s Comprehensive Reverse Shoulder was originally approved by the FDA in 2008, and has undergone some modifications since. It was approved under the agency’s 510(K) program, which is a streamlined process allowing an applicant to bypass human clinical trials if they are able to demonstrate that a product is similar enough — or, “substantially equivalent” — to another device that the agency previously approved.
Unlike traditional procedures employing total shoulder replacement, Zimmer Biomet’s reverse shoulder implant uses a ball for articulation on the glenoid side of the joint and a polyethylene bearing surface on the humeral side. The device configuration, according to a description submitted to the FDA by the manufacturer, “increases the lever arm of the deltoid muscle bundle to provide stability and the ability to raise the arm.”