Zimmer Biomet Shoulder Replacement Recall
Biomet, Inc. (acquired by Zimmer Holdings in 2015) received FDA clearance to market the Comprehensive Reverse Shoulder via the 510(K) program, which allows a medical device manufacturer to forgo human clinical trials if they are able to demonstrate that a product is "substantially equivalent" to another device that was previously approved by the agency. The Comprehensive Reverse Shoulder system is beneficial in individuals with rotator cuff tears who have developed a severe type of shoulder arthritis known as arthropathy and previously failed shoulder joint replacement.
The shoulder replacement recall was initiated in December 2016, when Zimmer Biomet sent an Urgent Medical Device Recall Notice and a Certificate of Acknowledgement asking its customers to quarantine certain Comprehensive Reverse Shoulder Humeral Trays after it was determined that the devices were are fracturing at a higher rate than is stated in the labeling. Products affected by the recall include Comprehensive Reverse Shoulder Humeral Trays (Model 115340) manufactured from August 25, 2008 to September 27, 2011, and distributed from October 2008 to September 2015. Recalled devices bear product codes KWS and PAO. The notice indicated that a Zimmer Biomet sales rep would remove the affected products from customer facilities.
According to the FDA, there are "no specific patient monitoring instructions related to this recall that are recommended beyond existing surgical follow up protocol." Fracture of a Comprehensive Reverse Shoulder may necessitate revision surgery, which could lead to permanent loss of shoulder function, infection or death.
In February 2016, Biomet, Inc. agreed to pay $350,000 to settle a shoulder replacement lawsuit filed on behalf of a Colorado man who had experienced fractures of two Comprehensive Reverse Shoulders. According to a complaint filed in the U.S. District Court, District of Colorado, the shoulder replacements received by the Plaintiff had been recalled by Biomet in 2010, due to complaints that the devices were fracturing at the joint between the trunnion and the baseplate. The Plaintiff underwent revision surgeries of his shoulder replacements in 2012 and 2013, at which time visual inspections revealed that the devices had fractured at the joint between the trunnion and the baseplate. (Case No. 1:14-cv-02667-REB-NYW)
Individuals who experienced a fracture of the Comprehensive Reverse Shoulder may be eligible to take legal action of their own. To learn more about filing a Zimmer Biomet shoulder replacement lawsuit, please visit Bernstein Liebhard LLP's website, or call 800-511-5092.
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Bernstein Liebhard LLP is a New York-based law firm exclusively representing injured persons in complex individual and class action lawsuits nationwide since 1993. As a national law firm, Bernstein Liebhard LLP possesses all of the legal and financial resources required to successfully challenge billion dollar pharmaceutical and medical device companies. As a result, our attorneys and legal staff have been able to recover more than $3.5 billion on behalf of our clients. Bernstein Liebhard LLP is honored to once again be named to The National Law Journal's "Plaintiffs' Hot List," recognizing the top plaintiffs firms in the country. This year's nomination marks the thirteenth year the firm has been named to this prestigious annual list.
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