The U.S. Food and Drug Administration (FDA) in 2008 approved Zimmer Biomet’s Comprehensive Reverse Shoulder implant. However, after only eight years on the market, the manufacturer recalled its implantable joint systems last December. The company issued the Class 1 Recall only after thousands of patients suffered from fractures in the humeral tray component. A Class 1 recall is the most serious type of recall, used for defective devices that can cause serious injury or death.
While the recall is limited, approximately 3,662 unsuspecting patients could be affected. Zimmer Biomet warns that patients with a fractured humeral tray may require a revision surgery – a surgery US Recall News described as dangerous. Patients could also experience permanent loss of shoulder function, infection and even death. According to Righting Injustice, the shoulder system is used in patients with extreme shoulder injuries, including rotator cuff tears and for patients who have a severe type of shoulder arthritis known as arthropathy and who have previously undergone failed shoulder joint replacement. Its unique design swaps the humeral head (ball) and glenoid (cup) to the opposite sides of the glenohumeral joint. The unique design was intended to achieve greater range of motion in patients receiving total shoulder replacement surgeries.
The Biomet Comprehensive Shoulder System is the most recent example of ill-fated products haphazardly entering the market. The joint system was quickly cleared through the controversial 510(k) process. Therefore, the system was never safety-tested in humans. This alternative approval process is allowed for devices that are similar to others that are already approved. Righting Injustice has denounced the process, explaining that it bypasses clinical testing and more rigorous FDA medical review.
If you or somebody you know had a Biomet Comprehensive Shoulder System used in a total shoulder arthroplasty and complications were experienced, you can contact Matt Munson, a lawyer in our Mass Torts Section, at 800-898-2034 or by email at Matt.Munson@beasleyallen.com. Matt will answer any questions you might have.
Source: Righting Injustice
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