WHAT IS THE ZIMMER BIOMET SHOULDER REPLACEMENT LAWSUIT?
If you or someone you know has had a Zimmer Biomet shoulder replacement device and experienced negative side effects such as fractures, loss of shoulder function, or infection, you may be entitled to compensation. The device has been recalled by the company and labeled by the U.S. Food and Drug Administration (FDA) as a Class I recall, the most serious class of recalls.
Some people, including your loved ones, may even experience death as a result of the device. It is vital to contact Pittman, Dutton, Hellums, Bradley & Mann immediately if any negative side effects are incurred. We are a consumer protection law firm that represents individuals and families throughout the United States, and we provide free consultations for those negatively affected by the Zimmer Biomet shoulder replacement.
- The device that is associated with a higher-than-anticipated fracture rate is the Comprehensive Reverse Shoulder Humeral Tray
- Recall of the device was initiated in December 2016, when Zimmer Biomet sent an Urgent Medical Device Recall Notice and a Certificate of Acknowledgement to affected patients
- The device was distributed between October 2008 and September 2015
- More than 3,660 devices have been recalled
- Zimmer Biomet agreed to pay $350,000 to settle a lawsuit brought forth in 2014 by a man who suffered fractures of two Comprehensive Reverse Shoulder implants
Patients who have undergone shoulder replacement surgery using the Zimmer Biomet Comprehensive Reverse Shoulder Humeral Tray are more likely than patients with other implants to require revision surgery. Every surgery in itself poses risks to the patient, who must undergo general anesthesia and work through rehab to recover. Having a second surgery increases risks such as infection, permanent loss of shoulder function, or something going wrong with the device implantation, among many other factors.
The problem with manufacturer Zimmer Biomet is that negligence in design and testing before the product was released and implanted into thousands of patients has caused life-threatening and sometimes life-ending problems. While the company marketed the device as a way to help patients regain a natural arm motion, it has had the opposite effect in many cases. The FDA approved the Comprehensive Reverse Shoulder Humeral Tray in 2008 through the 510(k) Pre-Market Approval process, which enables products that are substantially similar to products that are already on the market to be released, without a requirement of human clinical trials.
The 2016 recall isn’t the first issue Zimmer Biomet has experienced. In September 2010, the Comprehensive Reverse Shoulder Humeral Tray with Locking Ring (49mm standard) was recalled by Biomet because of complaints that the device was fracturing at the joint. In 2011, the Custom Comprehensive Reverse Shoulder Humeral Trays (bio-modular base 44mm standard) was recalled because some of the trays may contain a locking ring that was not assembled correctly. The FDA designated both these recalls as Class II, which indicates that the devices may cause temporary or medically reversible negative health issues.
Who Are Comprehensive Reverse Shoulder Humeral Tray Patients?
Patients who have received the Zimmer Biomet Comprehensive Reverse Shoulder Humeral Tray are typically those who have lost control of their natural arm movement. Many times, these patients have suffered a rotator cuff tear that is a severe type of shoulder arthritis, called cuff tear arthropathy. When patients do not respond to traditional shoulder replacement surgery, reverse shoulder replacement surgery may be recommended.
When considering the differences between traditional shoulder replacement surgery and reverse shoulder replacement surgery, in regular shoulder replacement, the implant replicates the normal anatomy of the shoulder. Like the name implies, in reverse shoulder replacement surgery, the design is reversed to be opposite the normal anatomy. This allows patients with cuff tear arthropathy to use different muscles to move the arm besides the rotator cuff.
How Can You Get Help for Pain and Suffering Caused by Zimmer Biomet?
Something that is distressing is that many patients who have had a Comprehensive Reverse Shoulder Humeral Tray implant are not aware of the risks they now face. They may not know that the pain they’re experiencing or second surgery they had to undergo is because of this device. Please share this information with anyone you know who has had a Zimmer Biomet shoulder replacement.
It is vital for shoulder replacement patients to talk with their doctors to find out what type of replacement they received, and contact our law firm if it was a Zimmer Biomet product. People who were harmed by the Zimmer Biomet Comprehensive Reverse Shoulder Humeral Tray replacement deserve to be compensated for their pain and suffering. Our experienced consumer protection law firm can help.
Please call (205) 322-8880 seven days a week for more information, or visit us online for a free consultation.
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