Zimmer Biomet Reverse Shoulder Lawsuit
Zimmer Biomet has issued a recall of the Comprehensive Reverse Shoulder Humeral Tray because the device fractures at a higher rate than stated on the device label. If a device fractures, it can require corrective surgery, which can place a patient at risk for permanent loss of shoulder function, infection or even death.
If you or someone you love experienced complications after having this device implanted, contact the experienced team of defective medical device lawyers at Janet, Janet & Suggs. You may be entitled to compensation for medical expenses, pain and suffering, and more through a Zimmer Biomet reverse shoulder lawsuit.
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Device Complications
The Comprehensive Reverse Shoulder is a surgically implanted shoulder replacement device that helps restore arm movement in patients with torn rotator cuffs who have developed arthropathy, a severe form of shoulder arthritis, and underwent a previously failed shoulder replacement.
The device was approved in 2008 through the U.S. Food and Drug Administration (FDA) 510(K) program, which allows for expedited approval of devices that are “equivalent” to those already on the market without having to undergo rigorous clinical trials.
Shortly after the device was approved, patients began to report of a number of complications, including:
- Device fracture
- Bone loss
- Device failure
- Corrective surgery
Those who have experienced these complications have legal options and may be entitled to file a lawsuit to recover compensation for damages.
Comprehensive Reverse Shoulder Recall
Since its approval in 2008, the Comprehensive Reverse Shoulder has been recalled twice.
The first recall was issued in September 2010 by the device manufacturer Biomet (now Zimmer Biomet). In an Urgent Medical Device Recall Notice, the company recalled 45 devices in eight states and stated that the device could fracture. The FDA classified the recall as a Class II recall because it could cause temporary or reversible injuries. That recall ended in 2011.
Several years later, on Dec. 15, 2016, Zimmer Biomet recalled the Comprehensive Reverse Shoulder implant by issuing an Urgent Medical Device Recall Notice to physicians and healthcare facilities. The recall advised that all use of the devices be halted and that sales representatives would remove the devices.
On Feb. 16, 2017, the FDA classified the recall as a Class I recall, which is the most serious level because of the potential for serious injury or death.
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Zimmer Biomet Reverse Shoulder Lawsuit
In February 2016, Biomet agreed to a $350,000 settlement in a lawsuit involving its Comprehensive Reverse Shoulder device. The lawsuit was filed on behalf of a man who claimed to have experienced two device failures, one in each shoulder. He had to undergo additional surgeries to remove and replace the failed devices.
If you or someone you love has experienced complications or undergone replacement surgeries after having a Zimmer Biomet Reverse Shoulder device implanted, do not hesitate to contact us to learn more about your legal options. You may be entitled to compensation for your pain and suffering, medical expenses, lost wages, and more.
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