The U.S. Food and Drug Administration (FDA) recently issued its highest level of recall for the Zimmer Biomet Reverse Shoulder. A class I recall is reserved for the most potentially dangerous device or drug defects, those that may cause serious injury or death. The full name of the device currently being recalled is the Biomet Comprehensive Reverse Shoulder Humeral. The device has recently been found to have a high fracture rate and a higher rate of revision surgeries as a result.
The Biomet Comprehensive Reverse Shoulder System
The Zimmer Biomet Reverse Shoulder is an artificial shoulder joint that is used to restore mobility and to reduce pain in patients who have damaged shoulders because of injury, trauma, or illness. A conventional shoulder replacement system is simply an artificial version of the normal shoulder joint, a ball attached to the upper arm and a cup in the socket to make a ball-and-socket joint. In a reverse shoulder system, the artificial joint attaches the cup to the upper arm and the ball to the socket. This reversed joint works better for certain patients with large rotator cuff tears.
High Fracture Rates Leads to Recall
Artificial joints can bring relief to patients with injuries and damaged joints, and can also restore mobility and flexibility, but there are also risks. Any artificial joint may fracture during use, but they are supposed to be designed to be sturdy through normal wear-and-tear and for a certain period of time. A joint may be considered faulty if it fractures in too many patients.
This has been the case with the Zimmer Biomet Comprehensive Reverse Shoulder System. All lots with the model number 115340 have been recalled by the FDA. The shoulder systems were manufactured between August 25, 2008 and September 27, 2011. This includes 3,662 shoulder systems. The FDA announced that the rate of fractures seen with these shoulder systems has been higher than what was stated on the device’s label.
The recall is the highest, a class I, because there is a potential for serious injury or even death because of the high fracture rate. When an artificial joint fractures, a patient has to undergo revision surgery. Like any major surgery, a revision surgery comes with serious risks: infection, excessive bleeding, completely losing function in the joint, and even death.
Zimmer Biomet’s Faulty Shoulder Could Lead to Lawsuits
Because the risk of fracturing has been greater than the company warned it would be in its device labeling, customers who experience a fracture may be able to file a lawsuit against Zimmer Biomet. This would not be the first time the company has faced such problems. Its Durom Acetabular Cup, a component in an artificial hip system, was designed to be more durable and to give patients greater ranges of motion.
However, the Cup led to higher rates of revision surgery in patients, and it was briefly recalled in 2008. A study of the Cup found that the way it was constructed was faulty. It did not adhere well enough to the bone and came loose in more patients than was reasonable. Lawsuits were filed against Zimmer Biomet over that faulty part. It is likely that people suffering from adverse effects of revision surgery because of the faulty reverse shoulder will also file lawsuits looking for compensation for medical costs and pain and suffering.