“Design” Issue Sparks Shoulder Implant Recall
On December 20, 2016, Zimmer Biomet issued an urgent recall for an essential component of the company’s Comprehensive Reverse Shoulder: the device’s humeral tray. As adverse event reports gathered by the US Food & Drug Administration show, this component appears to fracture after being implanted inside patients, leading to invasive corrective surgeries and significant pain. In fact, some patients have lost arm function permanently, after their Zimmer Biomet shoulder implant suddenly snapped during normal activities.
While Zimmer Biomet has now issued a Class I recall for over 3,000 Comprehensive Reverse Shoulder implants, the device has already led to severe injuries in hundreds of patients. According to federal regulators, Zimmer’s shoulder replacement device is linked to a range of debilitating fractures, including implant fractures, systemic infections and death. Many patients have already been forced to undergo major revision procedures, leading to pain, lost time at work and burdensome medical expenses.
FDA Determines “Device Design” Leads To Fractures
Several patients have already filed lawsuits against Zimmer Biomet, claiming the company made serious design errors in creating the Comprehensive Reverse Shoulder. In fact, the device’s manufacturer appears to agree with this characterization of events, explaining the recall as one based in “design” issues. The US Food & Drug Administration has added even more support to plaintiffs’ theories of defective design, concluding in an internal investigation that “device design” has led to an increased rate of shoulder implant failure.
Thousands Of Patients May Be Affected
While most patients will find relief through the use of traditional shoulder replacements, which attempt to recreate the shoulder’s natural anatomy, people who have lost rotator cuff function are better served by reverse shoulder implants. Reverse shoulder implants invert the shoulder’s anatomy, allowing patients with limited rotator cuff strength to regain arm mobility using a different muscle, the shoulder’s deltoid. Due to their unique design, reverse shoulder implants, including the Comprehensive Reverse Shoulder, are only right for certain patients:
- impaired rotator cuff function with severe arthoplasty (a form of arthritis)
- previously-failed shoulder joint replacement with impaired rotator cuff function
Considering this limited market, it’s no surprise that Zimmer Biomet’s recent recall is relatively small, affecting only 3,662 devices. More surprising, however, is that this exact shoulder implant has already been recalled at least once before – for strikingly similar reasons.
Zimmer Biomet is a relatively-new company, formed in 2015 when orthopedic manufacturer Zimmer acquired a second company, Biomet. The Comprehensive Reverse Shoulder, along with the device’s humeral tray, was originally developed by Biomet, gaining FDA approval in 2008. Apparently, problems soon began to surface. After only three years on the market, Biomet’s Comprehensive Reverse Shoulder was pulled off the market, after the manufacturer “received complaints regarding fracturing of the device.” The product returned to distribution soon after, reappearing in 2011.
Will Shoulder Implant Lawsuits End In Settlement?
The litigation surrounding Zimmer Biomet Comprehensive Reverse Shoulder implants is just beginning; it’s too early to predict how these shoulder replacement lawsuits will proceed. It’s notable, however, that Biomet has already settled at least one lawsuit involving the Comprehensive Reverse Shoulder system, a 2014 claim filed by a man who claimed to have suffered two independent implant fractures. After spending two years in a Colorado federal district court, the man’s lawsuit was resolved – through a $350,000 settlement offered by the device’s manufacturer.
Zimmer has a long and contentious history of civil litigation. In 2010, hundreds of lawsuits filed over the company’s Durom Cup hip implant were consolidated in the US District Court of New Jersey. After nearly four years of coordinated litigation, the manufacturer had already paid out around $56 million in settlements to plaintiffs who claimed that their own implants had fractured or moved out of position, forcing them back into the operating room.
Whether or not the company will take a similar path in resolving newly-filed Comprehensive Reverse Shoulder implants is unknown.
Contact A Zimmer Biomet Attorney Today
With Zimmer Biomet’s reverse shoulder implant now linked to severe complications, the attorneys at TheProductLawyers.com have begun to provide free legal consultations. Our experienced lawyers can help. If you or a loved one suffered an implant fracture, contact us today to learn more about your legal options at no charge and no obligation. Just call now or fill out our free contact form.
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