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The lawsuit involving the Zimmer Biomet Reverse Shoulder states the manufacturer of this medical device was negligent in its design, which is experiencing a high failure rate, and the need for revision surgery.
We are no longer accepting Zimmer Biomet cases.
Zimmer Biomet is being sued because its reverse shoulder implant has been failing at a rate higher than the company initially revealed.
Zimmer Biomet marketed its medical device as a way to help restore a patient’s natural arm movement, especially individuals who had suffered a rotator cuff tear known as “cuff tear arthropathy” (a severe type of shoulder arthritis), and who failed to respond to traditional shoulder replacement surgery.
Unfortunately, these implants have been failing, resulting in fractures and revision surgery. The surgery is extremely risky, and can cause a patient to lose use of the shoulder, and in some cases can result in death.
The specific implant subject to the recall is the Zimmer Biomet Comprehensive Reverse Shoulder System Humeral Tray Model 115340 manufactured between August 2008 and September 2011, and distributed between October 2008 and September 2015. Approximately 3,500 implants are subject to the recall.
A conventional shoulder replacement implant is designed to replicate the normal anatomy of a shoulder. In a reverse shoulder replacement, the design is reversed to be exactly opposite to a person’s natural anatomy.
The reverse total shoulder replacement supposedly works better than conventional shoulder implants for people with cuff tear arthropathy because it relies on different muscles to move the arm. Specifically, the reverse shoulder replacement relies on the deltoid muscle, instead of the rotator cuff, to stabilize and operate the arm. This type of surgery has become the third largest market in joint reconstruction, driven largely by the aging population and increasing levels of obesity.
The Zimmer Biomet Reverse Shoulder received FDA approval in 2008 through the controversial 510(k) Pre-Market Approval process, which allows manufacturers to bring products to market if they can show the products are “substantially similar” to an existing product already being sold and distributed.
In December 2016 Zimmer Biomet sent an Urgent Medical Device Recall Notice and a Certificate of Acknowledgement form to hospitals and physicians using certain reverse shoulder implants distributed over a seven year period. To read more, click Ortho Spine News
On December 15, 2016, Zimmer Biomet issued a voluntary recall of its 3,662 Comprehensive Reverse Shoulder Humeral implants distributed during the period 2008 – 2015. The company has asked for health care providers to remove all of the recalled implants from their shelves and return to the company.
The FDA has identified this recall as a Class 1 recall, meaning the faulty implants have the potential to cause serious injury or even death.
This is not the first time there have been problems with Zimmer’s Reverse Shoulder System. In 2010, the FDA issued a recall for the Comprehensive Reverse Shoulder Humeral Tray with Locking Ring. In 2015, there was a recall of the Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adaptor.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. To read more, click FDA Medical Device Recall
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