Zimmer Biomet recalled over 3,600 reverse shoulder replacements made before 2011 due to the risk of fractures, revision surgery, infections, disability, or death. The first lawsuit ended in a $350,000 settlement in 2016.
Need a Texas Zimmer Biomet Shoulder Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one was injured by a recalled shoulder implant, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.
Zimmer Biomet Shoulder Recall
February 16, 2017 — The FDA issued a Class I recall for a Zimmer Biomet shoulder replacement due to high rates of fractures and the risk of devastating complications.
What is the Risk?
Fractured shoulder implants may require another surgery to remove and replace the joint. This could cause serious complications like permanent loss of shoulder function, disability, infection, or death.
$350,000 Biomet Shoulder Lawsuit Settlement
In February 2016, Biomet Inc. paid a $350,000 settlement in a lawsuit over the Comprehensive Reverse Shoulder. The victim received two shoulder implants in 2009 and 2010. They were recalled in 2010. Both eventually failed at the joint between the trunnion and baseplate and required another surgery — Case No. 14-02667.
Other Biomet Shoulder Replacement Recalls
- September 2010: Biomet issued a Class II recall for the Comprehensive Reverse Shoulder Humeral Tray due to fractures between the trunnion and baseplate.
- April 2011: Biomet issued a Class II recall for the Custom Comprehensive Reverse Shoulder Humeral Trays that may contain a locking ring that was assembled incorrectly.
Urgent Warning to Surgeons
In December 2016, Zimmer Biomet issued a warning (PDF) to doctors about a high rate of fractures associated with Comprehensive Reverse Shoulder Humeral Trays that were manufactured before September 2011. Shoulder implants manufactured after September 2011 have “design enhancements that increase the strength of the device,” Zimmer said.
Shoulder Recall Product Information
The recalled shoulder implants were sold between October 2008 and September 2015:
- Number of Recalled Implants: 3,662
- Manufacturing Dates: August 25, 2008 to September 27, 2011
- Product Codes: KWS, PAO
- All Lots With Part #115340
- See a full list of recalled lots
What is the Comprehensive Reverse Shoulder?
The Zimmer Biomet Comprehensive® Reverse Shoulder Implant is designed to restore arm movement in people undergoing shoulder replacement surgery. It is beneficial for people with rotator cuff tears with a severe type of shoulder arthritis known as arthropathy (“Charcot Shoulder”) or after a previous shoulder replacement failed.
What is a Reverse Shoulder Surgery?
Unlike normal shoulder replacements, reverse shoulder replacements switch the “ball-and-socket” so a metal ball is attached to the shoulder socket (glenoid) and a plastic cup is attached to the end of the arm bone (humerus). This helps people who have a torn rotator cuff because it allows other muscles to move the arms.
Problems Unique to Reverse Shoulder Implants
Reverse shoulder replacements were first approved by the FDA in 2004. Like many new devices, these implants were soon linked to unique risks. The most common problems are joint instability, fracture, infection, nerve damage, and hematoma. There is very little data on long-term risks.
Treatment for Shoulder Infections
Up to 10% of all patients who undergo reverse shoulder surgery develop a serious infection. When infections do not clear up with antibiotics, the only option is surgery to wash out the joint with saline (salt-water) and scrape out any visible infection. It may also be necessary to remove the plastic liner and replace it with a new one.
Shoulder Replacement Fractures
Fracture of the shoulder baseplate or “humeral tray” is an ongoing issue with reverse shoulder replacements. If the patient’s bone does not attach to the baseplate, the shoulder will be unstable or loose. Locking screws can help reduce this risk.
Need a Zimmer Biomet Shoulder Lawyer in Texas?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $260 million in verdicts and/or settlements. Please use the form below to contact our Texas Zimmer Biomet shoulder lawyers for a free lawsuit review.