In February 2017, the U.S. Food & Drug Administration (FDA) announced a recall for certain Zimmer Biomet Comprehensive Reverse Shoulder devices due to a higher-than-expected rate of fracture. The agency designated the Zimmer Biomet shoulder replacement recall Class I, which indicates that the affected devices could cause serious injury or death.
Bernstein Liebhard LLP is investigating legal claims on behalf of individuals who experienced fracture of a Zimmer Biomet Comprehensive Reverse Shoulder. To learn more, please contact our Firm today by calling (888) 994-5118.
Reverse shoulder replacement is generally performed in patients with large rotator cuff tears who have developed a complex type of shoulder arthritis called “cuff tear arthropathy.” Traditional shoulder replacement is usually not an option for these patients, as it can result in pain and limited motion. The reverse total shoulder replacement relies on the deltoid muscle, instead of the rotator cuff, to power and position the arm.
Biomet, Inc., which was acquired by Zimmer Holdings in 2015, received clearance to market the Comprehensive Reverse Shoulder in 2008, via the FDA’s 510(k) program. This program allows a medical device to come to market without the benefit of human testing as long as the manufacturer can show that it is “substantially equivalent” to a previously-approved product.
On December 20, 2016, Zimmer Biomet issued an Urgent Medical Device Recall Notice and a Certificate of Acknowledgement regarding certain Comprehensive Reverse Shoulder Trays manufactured prior to September 2011 that had been associated with a higher-than-anticipated rate of fracture. The units affected by the Zimmer Biomet shoulder replacement recall were distributed between October 2008 and September 2015. Among other things, the notice asked customers to identify and quarantine all affected product currently in stock in order to facilitate retrieval by a Zimmer Biomet sales rep.
On February 16, 2017, the FDA announced that it had designated the Zimmer Biomet Urgent Medical Device Recall Notice a Class I recall, the agency’s most serious type of recall. Class I recalls are issued when there is a reasonable probability that use of a device will result in serious injury or death. According to the FDA, fracture of a Zimmer Biomet Comprehensive Reverse Shoulder may necessitate revision surgery to replace the implant. This could result in serious adverse health consequences such as permanent loss of shoulder function, infection or death.
Comprehensive Reverse Shoulder products have been involved in two prior recalls:
Both recalls were designated Class II by the FDA, which indicates that the products may cause temporary or medically reversible adverse health consequences
In February 2016, a $350,000 settlement was reached in a shoulder replacement lawsuit filed on behalf of a recipient of the Biomet Comprehensive Reverse Shoulder. According to the complaint, the plaintiff had received two Comprehensive Reverse Shoulders in 2009 and 2010. Both devices eventually failed at the joint between the trunnion and the baseplate, forcing the plaintiff to undergo revision surgery to remove and replace the implants. Both of the allegedly defective shoulders included components were involved in the 2010 Biomet shoulder replacement recall. (Case No. 14-02667) Read More
Individuals who underwent revision surgery following fracture of a Zimmer Biomet Comprehensive Reverse Shoulder may be entitled to compensation for medical bills, lost wages, pain and suffering, and more. To learn more about filing a Zimmer Biomet shoulder replacement lawsuit, please contact Bernstein Liebhard LLP at (888) 994-5118.
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