Zimmer Biomet Shoulder Replacement Lawsuits
Patients who had a Zimmer Biomet Reverse Shoulder implant are filing lawsuits after learning the implant has been associated with high failure rates, additional surgeries, and serious injuries. There have been 3,662 devices recalled and more than 2,700 cases have been filed against Zimmer Biomet, the device manufacturer.
If you’ve experienced pain, infection, or lack of mobility after having shoulder replacement surgery, or if you had to have an additional shoulder replacement surgery due to complications, contact your surgeon or doctor right away.
If your doctor confirms you had a Zimmer Biomet Comprehensive Reverse Shoulder Humeral Tray Model 115340 implanted, contact us. You may be eligible for compensation.
According to the lawsuits, the manufacturer allegedly knew about the risks, but failed to disclose them to the public. Lawsuits claim they negligently designed the shoulder implants, which lead to a mounting number of bone fractures and corrective surgery operations. Although the device was intended to restore the range of motion in patients who did not respond well to traditional shoulder replacement, the company allegedly concealed the higher than expected rate of failed surgeries.
The Facts: Zimmer Biomet Reverse Shoulder
When the Biomet* Comprehensive Reverse Shoulder came to market in 2008, it seemed like the ideal answer for patients, particularly those who were not viable candidates for traditional shoulder surgery. Many of these patients suffered from a serious type of arthritis known as cuff tear arthropathy. The reverse design relied on the deltoid muscle to help stabilize the arm without putting additional strain on the rotator cuff after replacement surgery.
Soon, however, complications were being reported to surgeons, doctors, and the FDA. By 2016, a complete recall all 3,662 of these devices was issued.
FDA Class 1 Recall
In December 2016 Zimmer Biomet issued a recall of its Comprehensive Reverse Shoulder Humeral implants distributed between October 2008 and September 2015. The FDA identified this as a Class 1 recall (its most serious recall) stating: “Use of these devices may cause serious injuries or death.”
The devices were fracturing at a higher rate than the label stated, and the FDA was concerned that fractures may result in revision surgeries, which could cause serious adverse health consequences including permanent loss of shoulder function, infection, or in rare cases, death.
Zimmer's Reverse Shoulder products are no stranger to recalls. In 2010, the FDA issued a recall for the Comprehensive Reverse Shoulder Humeral Tray with Locking Ring. In 2015, the Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adaptor was recalled.
Zimmer Biomet Reverse Shoulder Lawsuits
Zimmer Biomet Reverse Shoulder lawsuits claim that the manufacturer was negligent in its design of the reverse shoulder device and that it was not tested for safety before it was approved.
The device received FDA approval in 2008 through the 510(k) pre-market approval process. This process allows manufacturers to bring products to market if they can show the products are “substantially similar” to an existing product already being sold and distributed.
Zimmer Shoulder Replacement – No Safety Studies
When a medical device manufacturer wants to save time and money and rush a product to market, there’s a loophole in the FDA approval process in certain instances. The 510(k) approval process allows a manufacturer to skip the testing and approval process for “mostly low risk” (Class 1 and Class II) devices if they can show their product is “similar to those already cleared” for patient use. All the manufacturer needs to do is show the FDA evidence substantiating that their device is similar to those already approved on the market and that it appears to be safe.
When the 510(k) process was initiated in 1975, its intentions were good ones – to protect the consumer by bringing “similar” devices to market without forcing the device manufacturer to undergo costly and time-consuming testing, clinical trials, and other research which had already been done on the “predicate” device. As many devices went to market only to be yanked back out again, it became clear that the process had eventually morphed into a slippery slope of loopholes, and is now quite controversial among many in the legislature, medical industry, the FDA, and other agencies.
Bloomberg.com reports that 81% of the 113 withdrawn devices that the FDA deemed high-risk recalls in 2005 to 2009 were approved under the 510(k) process.
The high number of recalls has led some to suggest the process needs to be scrapped, or at the very least severely overhauled. The Institute of Medicine, for example, has stated that the FDA should require each device maker to prove that moderate-risk (or Class II, which includes the Zimmer device) products are safe and effective, and possibly test the devices on actual patients instead of approving through 510(k).
North Carolina Lawyers Can Evaluate Your Zimmer Biomet Claim – Free
If you received a Zimmer Biomet Comprehensive Reverse Shoulder Humeral Tray Model 115340 and you suffered side effects such as pain, infection, bone fractures, or additional surgeries, you may be entitled to compensation including:
- Medical expenses
- Lost wages
- Emotional and physical pain and suffering
Our representatives are available 24/7 to offer you a free and confidential evaluation of your case. You can also use our live chat feature or send in our secure and confidential form on this page. It takes just a few minutes to provide us the information we need to determine if you may have a case.
Call the Law Offices of James Scott Farrin at 1-866-900-7078 to find out if one of our North Carolina lawyers may be able to help you.
*Biomet was the manufacturer of the reverse shoulder device. Zimmer Holdings bought Biomet Inc. in 2015 and became Zimmer Biomet.