Back in 2007, the FDA approved Biomet’s Comprehensive Reverse Shoulder, a next-generation prosthetic combining multiple technologies, via its 510K protocol. As a result, this implant ended up on the market without any human testing, but three years later, fracturing components prompted a recall.
However, an improved product returned for 2011, only to be followed by a more serious FDA recall over higher-than-reported fracturing rates and the need for revision surgeries. Because of this ordeal, patients are suing Zimmer Biomet, now the manufacturer, for irreversible damage stemming from this system.
Through 510K, the FDA approves products if they’re similar to a manufacturer’s preexisting system. Biomet’s Comprehensive Reverse Shoulder, at the time, was touted as an implant designed to restore arm movement after patients with rotator cuff injuries had developed arthropathy, a type of arthritis. Candidates for the implant previously had unsuccessful attempts with shoulder joint replacement procedures.
As a result, doctors recommended these patients for reverse shoulder surgery, for which the first implants appeared in 2004. The procedure removes the shoulder’s ball-and-socket joint, replaces it with a metal ball, and, after cutting off the top of the arm bone, adds a plastic cup. After this procedure, regardless of the implant used, patients have complained of joint loosening, instability, and humeral tray or baseplate fracturing.
When Biomet’s shoulder implant debuted, the company claimed it combined five different systems available at the time. Yet, by 2010, the FDA issued a Class II recall concerning fracturing components. However, while its upgrade was allegedly stronger, it was part of a Class I recall at the end of 2016 for high fracturing rates, the need for revision surgery, and association with permanent loss of shoulder function, infection, and possibly death. The recall has involved 3,662 shoulder implants to date.
Following surgery, patients who received the Zimmer Biomet shoulder implant may have experienced:
- Metal poisoning
- Bone and tissue damage, including fractures requiring a second surgery
- Infections requiring device removal
- Rotator cuff damage
- Device misalignment or loosening, which can happen if the implant isn’t secured to the bone or other parts of the shoulder
- Full or partial joint dislocation
- Nerve injuries
- Allergic reactions
Along with all reports to the FDA, a study in the Journal of Shoulder and Elbow Surgery found that this surgical procedure has significant risks of pulmonary, cardiac, and abdominal complications. Particularly, if the implant fractures, patients have a fatality rate six times the general population. Yet, as complications may stem from inadequate soft tissue, deltoid tension, implant positioning, and infection, reliable revision treatment doesn’t exist, and attempting to correct it often has an unsatisfactory outcome.
Patients dealing with long-term pain put their trust in doctors, who, in turn, count on device manufacturers to put a reliable, safe prosthetic on the market. Because of the shoulder’s high fracturing rates and resulting health complications, plaintiffs have been coming forward to file individual lawsuits against Zimmer Biomet for introducing an inadequately tested system.
Were you one of this device’s recipients, only to experience complications and permanent shoulder damage as a result? Trantolo & Trantolo believes such medical device manufacturers need to be held accountable for their actions. If you believe you have a claim, contact our team today to present your case.