Zimmer Biomet has recalled certain Comprehensive Reverse Shoulder components due to a high rate of fracture. A shoulder replacement fracture usually requires revision surgery, which can lead to permanent disability and other adverse health consequences.
Patients who suffer a Zimmer Biomet shoulder replacement fracture are likely to require revision surgery, as well as extensive physical therapy and rehab. However, many will never regain full function of their shoulder. If you or loved one were seriously injured by the fracture of a Zimmer Biomet Comprehensive Reverse Shoulder, please contact Bernstein Liebhard LLP at (888) 994-5118 to learn how you might be able to obtain compensation for your pain and suffering.
Biomet, Inc. brought the Comprehensive Reverse Shoulder to market in 2008. The device is often used to treat patients with rotator cuff tears who suffer from a severe type of shoulder arthritis known as arthropathy, as well as those who have experienced failure of a previous shoulder replacement. Today, the Comprehensive Revere Shoulder is manufactured by Zimmer Biomet, a company formed in 2015 through the acquisition of Biomet by Zimmer Holdings.
The U.S. Food & Drug Administration (FDA) cleared the Comprehensive Reverse Shoulder via its 510(K) program. This program does not require a device maker to conduct human clinical trials as long as the company can demonstrate that a new product is “substantially equivalent” to another device previously approved by the FDA.
Within just years of its approval, Biomet issued two separate recalls for devices that were part of the Comprehensive Reverse Shoulder line:
In 2014, a lawsuit was filed in the U.S. District Court, District of Colorado, by a man who experienced two Zimmer Biomet shoulder replacement fractures. According to his complaint, both of his failed Comprehensive Reverse Shoulders were among those recalled in 2010. The case was settled in 2016 for $350,000. (Case No. 14-02667) Read More
On December 20, 2016, Zimmer Biomet issued an Urgent Medical Device Recall Notice and a Certificate of Acknowledgement regarding certain Comprehensive Reverse Shoulder Trays that had been associated with a higher-than-anticipated rate of fracture. Devices subject to the notice were manufactured prior to September 2011, and distributed between October 2008 and September 2015.
The FDA designated the Zimmer Biomet’s notice a Class I recall in February 2016 and warning that a Comprehensive Reverse Shoulder fracture may require revision surgery. Risks of shoulder revision include the permanent loss of shoulder function, infection or death. A Class I recall is the FDA’s most serious recall category, and indicates that use of a device may result in serious or fatal injury.
Bernstein Liebhard LLP offers free legal consultations to victims of Zimmer Biomet shoulder replacement fracture. To discuss a claim with a member of our legal team, please call (888) 994-5118.
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