The U.S. Food & Drug Administration issued a recall in February 2017 of the Zimmer Shoulder Replacement due to injury reports and recent research showing the medical device may have a higher incidence of fractures. The recall is a Class 1, the most serious category for medical devices that have been linked to serious injury or death.
The Zimmer Shoulder Replacement Recall is primarily for the company’s Comprehensive Reverse Shoulder replacement system, which has been responsible for a number of serious complications in patients. The Comprehensive Reverse Shoulder replacement is most often used in patients with torn rotator cuffs with severe arthritis. It is an implant designed to help restore arm movements that may have been lost due to disease or injury.
A reverse shoulder replacement is riskier than a traditional shoulder replacement and is used when there is severe damage to shoulder tendons. In reverse shoulder replacements, the implant’s head is attached to the socket side of the joint, which is opposite of where the head is naturally located.
There have been a number of injury reports associated with this procedure using the Zimmer Comprehensive Reverse Shoulder replacement, including during the surgery itself. The Comprehensive Reverse Shoulder replacement has been linked to unexpected fractures, which can lead to permanent loss of shoulder movement, infection and even death.
Zimmer Biomet issued its own recall of the device in December 2016, requesting that the Comprehensive Reverse Shoulder replacement implants be discontinued from use and returned to the company. The recall covers devices distributed between October 2008 and September 2015. The company’s recall advised medical personnel to follow existing follow-up protocols, but did not provide any recommendations for patients who had suffered an injury from the device.
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