Have You Experienced Complications From the Device?
Zimmer Shoulder Replacement Problems
Zimmer Biomet Comprehensive Reverse Shoulder
A recall of Zimmer Biomet’s Comprehensive Reverse Shoulder has been issued due to its high fracture rate. The Comprehensive Reverse Shoulder is a shoulder replacement device surgically implanted in patients to help restore arm movement. First approved for use in 2008, the device has been used in patients who have experienced rotator cuff tears and developed a severe type of shoulder arthritis known as arthropathy, or had a previously failed shoulder joint replacement.
The device has been found to fracture at a higher rate than expected. Fracturing may result in revision surgeries, which could cause serious injuries including permanent loss of shoulder function or infection.
On December 20, 2016 Zimmer Biomet sent an Urgent Medical Device Recall Notice and a Certificate of Acknowledgement form to physicians and healthcare facilities, urging them and sale representatives to acknowledge the recall and remove all affected devices from stock.
This Class I recall on the shoulder replacement device—the most serious type of recall issued by the FDA—affects Zimmer Biomet’s Comprehensive Reverse Shoulder System Humeral Tray Model 115340 devices manufactured between August 25, 2008 and September 27, 2011 and distributed between October 2008 and September 2015.
This is not the first recall for the device, however. In 2010, just two years after it was introduced to the market, the company recalled 45 devices in eight states due to fracture risks.
Zimmer Biomet Comprehensive Reverse Shoulder Lawsuit
In February 2016, Biomet settled a lawsuit concerning its Comprehensive Reverse Shoulder device brought by a man claiming he experienced device failure in both of his shoulder implants, leading to revision surgeries. The case reportedly settled for $350,000.
What Does This Mean for You?
Experienced attorneys are investigating the risks of Zimmer Biomet’s Comprehensive Reverse Shoulder device and are monitoring all developments. If you or a loved one received a Zimmer Biomet Comprehensive Reverse Shoulder device and have experienced complications or underwent revision surgery, please contact us.