The U.S. Food and Drug Administration (FDA) identified the recall as Class I, the most serious kind of recall, in which a product poses a “reasonable probability” that use of or exposure to the product could cause serious injuries or death.
A 2016 study found that cracks in titanium Biomet Comprehensive Reverse Shoulder humeral trays with small taper fillets need only grow to the thickness of the humeral tray (less than 1.5 mm) to cause a “catastrophic fracture of the implant.”
The FDA points out that a fracture in the tray could lead to “revision surgeries which could cause serious adverse health consequences such as permanent loss of shoulder function, infection, or rarely, death.”
If you have required revision surgery to repair or replace a defective Biomet Comprehensive Reverse Shoulder implant, or if your doctor has advised that you may need revision surgery, you may want to talk to an attorney. Weitz & Luxenberg offers a free consultation to help you determine if you are able to seek compensation for medical and other expenses associated with your injury.
What Is a Reverse Shoulder Implant?
For a free consultation and more information about your legal options, please contact us today.
Get a Free Case Review
Reverse total shoulder arthroplasty (rTSA), or replacement, gets its name from the way the implant “reverses” an aspect of human anatomy. Human shoulders consist of a ball-and-socket joint, with the ball atop the upper arm (humerus) bone and the socket (glenoid) on the shoulder blade. The Biomet Comprehensive Reverse Shoulder and other rTSA implants reverse this arrangement, putting the ball on the shoulder blade and socket on the upper arm.
In an rTSA implant, a humeral tray locks onto an implant stem mounted in the patient’s upper arm. A polyethylene component then locks onto the humeral tray and works as a new joint bearing.
The Biomet Comprehensive Reverse Shoulder is indicated for “use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.”
The FDA approved the first rTSA implant in the U.S. in 2003. By 2011, roughly a third of the more than 66,000 shoulder replacements performed annually in the U.S. were rTSA implants.
Nerve Damage and Other rTSA Complications
The complication rate for rTSA implants has been reported to be three to five times that of conventional shoulder replacements and may include:
- Neurological injury
- Dislocation or instability
- Fractures on the shoulder blade
- Hematoma – blood clotting in surrounding tissue
- Erosion of the shoulder blade
Study Found Potential for Device to Lead to Fractures
A 2016 study found “fatigue failure is a concern for some reverse shoulder components.”
The study looked specifically at Biomet Comprehensive Reverse Shoulder humeral trays. The trays included in this study were made from either a cobalt/chromium (CoCr) alloy or titanium. The researchers compared the two and found titanium versions were far more likely to fail than CoCr trays.
FDA and Biomet Actions
The Biomet Comprehensive Reverse Shoulder System received FDA approval through the agency’s 510(k) process on December 12, 2007. The process allows device manufacturers to market a new medical device so long as they can show it is “substantially equivalent” to an existing FDA-approved device.
Adverse event reports to the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database detail problems with Biomet Comprehensive Reverse Shoulder humeral trays fracturing. In one case, a patient heard a “loud pop” after rolling over in bed. The patient required surgery to remove and replace the humeral tray after radiographs indicated it had possibly fractured. In another report, a humeral tray fractured when the patient reached behind the driver’s seat of a car. This patient also required revision surgery to remove the fractured humeral tray.
Prior to the 2016 recall, Biomet issued another recall in 2010 for certain Comprehensive Reverse Shoulder humeral trays. The 2010 recall affected only a few devices, but the company advised implanting surgeons to monitor patients already implanted for potential fractures.
Weitz & Luxenberg
If you have needed revision surgery because of a recalled Biomet Comprehensive Reverse Shoulder implant, have been informed you may need revision surgery, or are experiencing adverse symptoms due to your Comprehensive Reverse Shoulder implant, Weitz & Luxenberg can help you seek justice and compensation for your injuries.
Weitz & Luxenberg has a long history of fighting for victims of faulty medical devices and corporate negligence. Attorneys in our Defective Drugs and Devices Unit have been at the forefront of complicated, joint replacement litigation.
Weitz & Luxenberg can help you understand exactly what your options are. Call us at (844) 834-5056 or fill out the contact form on this page, and one of our client representatives will be in touch with you about your potential case.