For many patients receiving the Biomet Comprehensive Reverse Shoulder Implant manufactured by Zimmer Biomet, the device offered hope of increased flexibility and function. Unfortunately, the U.S. Food and Drug Administration (FDA) recalled Zimmer’s shoulder implant in February 2017 because the device has a high rate of failure and many patients have suffered complications.
What Is The Reverse Shoulder Implant?
For some patients, standard shoulder replacement surgery is not possible because of previous injuries like torn rotator cuffs or arthritis in the shoulder. These patients instead undergo a reverse shoulder implant surgery where the shoulder implant uses the deltoid muscle, rather than the rotator cuff, to position the patient’s arm.
The Biomet Comprehensive Reserve Shoulder Implant Model 115340 was approved in 2007 and has since been used in thousands of surgeries in the U.S. The implant was approved through the 510(k) premarket approvals process, which allows the approval of devices similar to ones already on the market without the rigorous clinical trials usually required. By 2010, the company was receiving reports of device failure and the FDA issued a Class II recall in December 2010 for parts of the implant.
Biomet Shoulder Device Class I FDA Recall
In early February 2017, the FDA issued a Class I recall, the most serious type of recall issued by the agency, for thousands of reverse shoulder implants from Zimmer Biomet. The recall was initiated because the Biomet shoulder implant has a higher rate of fracture than advertised by the manufacturer. Fractures caused by the device can not only cause pain, but will also often require a revision surgery to replace the device.
The Dangers of the Zimmer Biomet Shoulder Implant
When the Zimmer Biomet Reverse Shoulder Implant fractures inside a patient’s body, the patient can suffer a variety of serious and potentially permanent side effects. Some of the most commonly reported side effects of the defective device include:
- Bone loss
- Increased risks of infection
- Loss of function
- Loss of feeling
- Permanent loss of shoulder movement
- Weakness in the shoulder joint
Many patients with Zimmer Biomet implants must undergo revision surgeries. Unfortunately, revision surgeries also come with many risks, including infection or even death.
The Manufacturer Has Already Settled One Case
A Colorado man filed a lawsuit against Zimmer Biomet after both of his reverse should implant devices failed, requiring revision surgeries. Zimmer Biomet settled the lawsuit for $350,000 before it went to trial in February 2016.
Zimmer Biomet Shoulder Implant Lawyers
When a medical device is implanted in a patient’s body, even a minor issue can become life threatening. Manufacturers have a responsibility to protect consumers from harm. When a patient faces injury or even death due to a defective device, the manufacturer may be responsible for compensating them or their loved ones.
If you received a Zimmer Biomet Reverse Shoulder Implant and suffered complications, call the experienced Zimmer Biomet shoulder implant law firm of Blizzard & Nabers LLP today. We can help you understand your legal options and pursue compensation on your behalf. Contact us today to schedule a free consultation.