Class I Recall Issued for Zimmer Biomet Shoulder ReplacementFeb 22, 2017
Fractures Reported with Comprehensive Reverse Shoulder System
Zimmer Biomet is recalling its Comprehensive Reverse Shoulder System, a shoulder replacement device, following reports of fracture. The recalled product is implanted in patients with a rotator cuff tear. The recall has been designated as Class I by the U.S. Food and Drug Administration (FDA), the most serious recall status.
Parker Waichman LLP is a national law firm with decades of experience representing clients in medical device injury litigation. The firm continues to offer free legal consultations to individuals with questions about filing a Zimmer Biomet Comprehensive Reverse Shoulder System lawsuit.
According to a recall notification posted on the FDA website, Zimmer Biomet recalled the Comprehensive Reverse Shoulder because they are fracturing at a higher rate than disclosed on the label. The product is intended to improve range-of-motion and mobility in patients with a torn rotator cuff who have arthropathy (a form of serious arthritis in the shoulder) and a shoulder joint replacement that previously failed.
"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 states.
The recall was designated as Class I by the FDA, meaning that there is a reasonable risk of serious injury or death associated with use of the recalled product. Class I is the most serious recall label.
In this case, the recall alert warns that "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 product, known by its trade name as the Biomet Comprehensive Reverse Shoulder Humeral, was manufactured between August 2008 and September 2011. The shoulder replacement device was distributed between October 2008 and September 2015.
The recall affects 3,662 shoulder replacement devices in the U.S.
Zimmer Biomet Comprehensive Reverse Shoulder Background
Biomet has issued recalls for its Comprehensive Reverse Shoulder products previously in 2010 and 2011. One of these recalls triggered a lawsuit, resulting in a $350,000 settlement.
In September 2010, Biomet recalled its Comprehensive Reverse Shoulder Humeral Tray with Locking Ring because the device may fracture. In April 2011, another recall was issued for Comprehensive Reverse Shoulder Humeral Trays because the locking ring may be incorrectly assembled. The FDA designated both recalls as Class II.
Class II recalls indicate situations where a recalled device can lead to temporary or medically reversible health problems. These recalls also indicate situations where the chance of serious injury is remote.
In 2016, a man who sued over the Biomet Comprehensive Reverse Shoulder replacement received a $350,000 settlement. The plaintiff had the devices implanted in both shoulders in 2009 and 2010. The lawsuit, filed in the U.S. District Court, District of Colorado, alleged that both devices had failed, leading to injuries.
The injuries relate to the 2010 recall, the lawsuit alleged. In 2010, Biomet cited reports of fracturing at the joint between the trunnion and the baseplate. The company even had a specially designed tool to remove the broken component, the suit alleged. The complaint states that the plaintiff's shoulder replacements failed when the trunnion snapped off, due to the defective nature of the device.
The FDA approved the Biomet Comprehensive Reverse Shoulder in 2008. Biomet obtained approval through 510(k), a route that circumvents the need for clinical testing if manufacturers can prove that their products are "substantially equivalent" to a previously approved product. By FDA definitions, substantial equivalence means that a new product is at least as safe as a previously approved product (called a predicate). However, devices have been approved this way even when the predicate had safety issues of its own.
This contrasts to the FDA's stricter "premarket approval" (PMA) process, which requires device makers to submit clinical data proving that their products are safe and effective before gaining approval.
Some safety advocates and experts have criticized the use of 510(k) for certain medical products, such as metal-on-metal hip implants and transvaginal mesh. In fact, many medical device injury lawsuits focus on products cleared through 510(k). Plaintiffs allege that manufacturers failed to properly test the product before gaining approval. 510(k) is only intended for low and medium risk products, but some devices classified as high-risk, such as metal-on-metal hip replacements, were cleared through 510(k) due to a regulatory loophole.
Filing a Zimmer Biomet Shoulder Replacement Lawsuit
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).