In 2008, the U.S. Food and Drug Administration (FDA) approved Zimmer Biomet’s Comprehensive Reverse Shoulder implant, US Recall News reports. After only eight years on the market, the manufacturer recalled its implantable joint systems last December, according to the Jere Beasley Report.
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 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.
The shoulder system is used in patients with extreme shoulder injuries, including rotator cuff tears and patients who have a severe type of shoulder arthritis known as arthropathy who have previously undergone failed shoulder joint replacement, according to Righting Injustice. 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 and, therefore, 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 it, explaining that it bypasses clinical testing and more rigorous FDA medical review.
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If the Biomet Comprehensive Shoulder System was used in your total shoulder arthroplasty and you have since experienced complications, call Beasley Allen at 800-898-2034 or contact Matt Munson, a lawyer in our Mass Torts section, at Matt.Munson@beasleyallen.com.
US Recall News
Jere Beasley Report (February 2017)