FDA Recalls Biomet Shoulder Replacement Device
The FDA issued a Class I recall for Zimmer-Biomet’s Comprehensive Reverse Shoulder Humeral Tray (Model 115340). They warn that use of the Biomet shoulder device may cause serious injury or death because the devices are fracturing at a higher rate than stated on the label. This class of recall is the most serious since there is a high probability the device will cause serious health issues or death. They urge doctors to monitor patients carefully with the recalled device. The FDA estimated close to 4,000 people have the device.
About the Biomet Shoulder Device
Doctors surgically implant the Comprehensive Reverse Shoulder Humeral Tray as a shoulder replacement device to help restore arm movement. Many patients received this device after either rotator cuff tears, arthritis induced arthropathy, or a previously failed shoulder joint replacement.
In 2007, the FDA approved the device under the 510(k) premarket program. Biomet only showed the new device was similar to others currently on the market. This bypassed the need for rigorous clinical safety and efficacy studies to gain approval.
Close to 50,000 Americans, get shoulder replacement surgery each year. They expect their device will alleviate their pain. Instead, many are facing horrific issues stemming from their device breaking apart. These include bone loss, malpositioning of the device, infection, additional surgeries and sometimes death.
Not the First Recall
In 2010, Biomet pulled around 45 humeral tray and 45 locking ring components from distribution centers in 8 states. This is when they noted the first round of fracturing complaints. However, the FDA only labeled this recall as a Class II. This meant the device could cause temporary or reversible health consequences. The FDA halted the recall a year later.
The eight states involved in the recall were New York, Virginia, Maryland, Alabama, Colorado, South Dakota, Texas, and Oklahoma.
If You Had Shoulder Replacement Surgery
Therefore, if you had shoulder replacement surgery and your device fractured, contact us today. We will reach out to your doctor and find out if you have the recall device. Also, patients harmed by this device may be able to seek compensation for medical expenses, wages lost and other damages. The attorneys at the Michael Brady Lynch Firm know what it takes to go up against these manufacturers to get clients what they need. Contact us today for a free consultation.