Zimmer Biomet’s Comprehensive Reverse Shoulder System Parker Waichman LLP is investigating potential lawsuits on behalf of individuals implanted with Zimmer Biomet’s Comprehensive Reverse Shoulder System, a shoulder replacement device implanted in patients with rotator cuff tears.
In December 2016, the shoulder replacement product was recalled due to a high rate of fracture. Patients who experience a fracture with the Comprehensive Reverse Shoulder System may experience adverse events such as permanent loss of shoulder function; infection; and, in rare cases, death. The U.S. Food and Drug Administration (FDA) placed its most-serious “Class I” label on the recall. A Class I Recall designation means that the recall involves “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death,” according to the agency.
Our firm has decades of experience in medical device injury litigation. If you or someone you know has questions about filing a lawsuit involving Zimmer Biomet’s Comprehensive Reverse Shoulder System, contact one of our experienced product liability attorneys today.
Class I Recall Issued Due to High Rate of Fracture
The Zimmer Biomet Comprehensive Reverse Shoulder is designed for patients diagnosed with rotator cuff tears who are diagnosed with arthropathy, a severe type of shoulder arthritis, and who have also had a shoulder joint replacement in the past that failed. The shoulder replacement device is intended to give these patients improved mobility.
Zimmer Biomet recalled the shoulder replacement device in December 2016 because the device was fracturing at higher-than-expected rates. If the shoulder replacement device fractures, patients may undergo revision surgery and suffer from permanent loss of function in the shoulder, or infection. Death may also occur in rare cases.
“Zimmer Biomet is recalling the Comprehensive Reverse Shoulder because these devices are fracturing at a higher rate than is stated in the labeling,” the recall notification indicates. “Fractures may result in revision surgeries which could cause serious adverse health consequences such as permanent loss of shoulder function, infection, or rarely, death.”
The trade name for the recalled product is the Biomet Comprehensive Reverse Shoulder Humeral. The recall affects all lots with part number 115340. Zimmer Biomet distributed the recalled shoulder replacement from October 2008 to September 2015. The devices were manufactured from August 25, 2008 to September 27, 2011. A total of 3,662 units were recalled.
The company sent an Urgent Medical Device Recall Notice and a Certificate of Acknowledgement to affected customers. Zimmer Biomet has asked customers review the information and ensure that appropriate staff is aware of the recall. The notice also indicated that any affected devices should be identified and quarantined.
Biomet Shoulder Implant Recalled in the Past
Parker Waichman notes that Biomet Comprehensive Reverse Shoulder products have been recalled in the past. The Comprehensive Reverse Shoulder Humeral Tray with Locking Ring was recalled in September 2010 due to a risk of fracture. The company sent an Urgent Medical Device Recall Notice to customers detailing the recall.
The FDA classified the recall as Class II, meaning that the recalled product may lead to temporary or medically reversible health problems or indicates situations in which the risk of serious injury is remote. The recall was terminated in July 2011.
Another recall was initiated in April 2011 for Comprehensive Reverse Shoulder Humeral Trays because the products may contain a locking ring that is incorrectly assembled. Biomet launched the recall “…following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that is incorrectly assembled,” the recall notice indicates. The FDA also designated this recall as Class II. The recall was terminated in February 2013.
Biomet Shoulder Recall Lawsuits
Court records show that Biomet has faced litigation over its Comprehensive Reverse Shoulder Replacements. In 2016, a Biomet shoulder replacement lawsuit resulted in a $350,000 settlement. The plaintiff is a man who suffered injuries, allegedly due to the defective shoulder implant. The injuries relate to the component recalled in 2010. The plaintiff alleges that his injuries were caused by the recalled component. The lawsuit was filed in the U.S. District Court, District of Colorado.
According to the complaint, the plaintiff underwent shoulder replacement surgery in September 2009. Biomet’s Comprehensive Reverse Shoulder was implanted in his left shoulder at the time. The following year, the same device was implanted in his right shoulder. According to the lawsuit, the surgery reverses the anatomy of the shoulder so that patients ultimately experienced improved control and mobility with their arm. With the shoulder replacement device, the ball is connected to the scapula, or shoulder blade, and the socket is placed on top of the humerus. The device is supposed to give patients better mobility by giving the deltoid muscle control to raise the arm.
Within only a few years, the lawsuit indicates, the plaintiff allegedly suffered failure of both shoulder replacement devices. Failure occurred at the joint between the trunnion and the baseplate. The plaintiff subsequently suffered pain, and lost function of his shoulder. To address these complications, a revision surgery was performed to remove and replace the shoulder devices.
The 2010 recall was issued due to reports of fracturing at the joint between the trunnion and the baseplate, the lawsuit points out. Additionally, the plaintiff states that Biomet developed a special tool specially designed the remove the trunnion. Allegedly, the defective nature of the device causes the trunnion to snap off, leading to injuries and complications.
Court records indicate that the lawsuit was slated to go to trial on February 29, 2016; however, the plaintiff filed an Order on February 4, 2016 requesting an entry of judgment. A judgment of $350,000 was entered, per the Order.
Biomet Comprehensive Reverse Shoulder Device Approved through 510(k)
The FDA approved the Comprehensive Reverse Shoulder in 2008 through the 510(k) route, a fast-track review process that has come under scrutiny in light of certain controversial medical devices that have been associated with serious health issues. When devices are approved through 510(k), this means that manufacturers do not have to perform clinical testing to prove that their products are safe and effective. Devices cleared through 510(k) only need to be proven “substantially equivalent” to a previously approved device, known as a predicate device. A product may be cleared through the 510(k) even if the predicate to which it is “substantially equivalent” has had safety issues of its own.
To the FDA, substantial equivalence means that the new product is at least as safe as its predicate. Only devices that are classified as low or moderate risk were intended for 510(k). High-risk devices were not supposed to be cleared in this manner. The FDA has a more rigorous approval route for high-risk devices known as premarket approval (PMA), which requires device makers to submit clinical data proving that their products are safe and effective before selling and implanting them in patients.
There is controversy and debate surrounding the 510(k) process concerning certain medical devices. Plaintiffs involved in product liability litigation, patient safety advocates, and experts have argued that this expedited route is unsafe for certain products. For example, transvaginal mesh implants and metal-on-metal hip implants were both cleared through 510(k). These devices have been the subject of thousands of personal injury lawsuits. Metal-on-metal hip implants are a high-risk device, but they were approved through 510(k). Transvaginal mesh, in light of safety concerns, were reclassified as a high-risk device; this means that the mesh now needs to undergo clinical testing.
A number of personal injury and product liability lawsuits have been filed over medical devices that were approved through 510(k) route. Plaintiffs allege that the device makers failed to properly test the devices, and failed to warn patients and the medical community about the risks.
Need Legal Help Regarding Reverse Shoulder System?
Parker Waichman has years of experience representing clients in medical device injury lawsuits. If you or someone you know is interested in filing a Zimmer Biomet Comprehensive Reverse Shoulder System lawsuit, contact one of our experienced product liability lawyers today. Our firm offers free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).