Zimmer Biomet Comprehensive Reverse Shoulder System® — An Urgent Recall
Reverse shoulder replacement surgery is a complex procedure. It is most beneficial for patients with rotator cuff tears who have developed arthropathy, a form of arthritis. Patients who had previously unsuccessful shoulder replacement surgeries may also be candidates for reverse shoulder surgery as a means of revision.
Zimmer Biomet is a leading manufacturer of joint replacement devices, including their Comprehensive Reverse Shoulder®. After numerous reports of device fracturing, the company issued a recall.
About the Recall
More than 3,600 devices were recalled. The specific model is the Zimmer Biomet Comprehensive Reverse Shoulder System® — Humeral Tray Model 115340. It was distributed between October 2008 and September 2015.
Zimmer Biomet® sent an urgent recall notice to health care providers in December 2016. In February 2017, the Food & Drug Administration (FDA) addressed the matter. They designated the recall as Class I — the most serious classification — stating these devices were fracturing at a much higher rate than specified on the label.
Alarming Complication Rates
Reverse shoulder implants like Zimmer’s product may have complication rates three-five times higher than conventional shoulder replacements. Reported complications include:
- Hematomas ( blood clotting)
- Neurological injuries
- Shoulder dislocation
- Instability of the shoulder
- Shoulder blade fractures
- Shoulder blade erosion
In some cases, these complications could lead to permanent loss of shoulder function, leaving patients disabled. In worst-case scenarios, the FDA recall notes that these issues could lead to death.
A New Set of Concerns
While reverse shoulder surgery is an innovative option for a certain set of patients, it is a relatively new procedure. Zimmer Biomet has issued multiple recalls on reverse shoulder systems, including previous recalls in 2010 and 2011, for similar concerns around fracturing, as well as a manufacturer errors.
Schedule a Free Consultation
Ward Black Law helps provide justice for people who faced serious injuries or underwent revision surgery after a reverse shoulder replacement. We can help you pursue damages for your injury or simply answer your questions about the recall.
Call or text us at 1-800-531-9191 or email us at firstname.lastname@example.org. We are happy to answer your questions at no charge.