Zimmer Biomet has recently been the target of a recall of its reverse shoulder system after numerous reports have been received that the device is causing personal injury to patients.

Zimmer Biomet Shoulder Replacement Recall

The FDA recently issued a Class 1 recall of the Comprehensive Reverse Shoulder System. This type of recall is the most serious that can be issued. Class 1 recalls indicate that the device being recalled from the market can potentially result in serious injury or death of the patient. The Biomet shoulder replacement recall falls under this category.

Biomet’s reverse shoulder system was designed to be used with patients who could not have traditional shoulder replacements due to their tendons being too weak to support that type of implant. The reverse shoulder system is attached on the reverse side of the typical attachment point for a traditional shoulder replacement.

Unfortunately, the location of the attachment is causing patients to develop shoulder fractures as a result. Many of these fractures were actually occurring during the surgery designed to repair the shoulder with the Comprehensive Reverse Shoulder System.

According to the FDA website, “Zimmer Biomet is recalling the Comprehensive Reverse Shoulder because these devices are fracturing at a higher rate than is stated in the labeling. Fractures may result in revision surgeries which could cause serious adverse health consequences such as permanent loss of shoulder function, infection, or rarely, death.”

A total of 3622 devices are being recalled. These devices affected by the shoulder replacement recall were manufactured between August 2008 and September 2011 and would’ve been implanted in patients between October 2008 and September 2015.

In December 2016, Zimmer Biomet began sending shoulder replacement recall notices to physicians that included instructions on how to quarantine and return the devices affected under the recall. Representatives from Zimmer Biomet indicated that after the devices were quarantined, they would be picking up the devices from the facilities.

The FDA said that Biomet’s “notice also stated that there are no specific patient monitoring instructions related to this recall that are recommended beyond existing surgical follow-up protocol.”

Taking Legal Action over Devices Affected by the Biomet Shoulder Replacement Recall

If you or a loved one suffered a fracture after having been implanted with Zimmer Biomet’s Comprehensive Reverse Shoulder System, you may be eligible to seek legal compensation as a result of your injury.

Plaintiffs filing product liability lawsuits against device manufacturers may be able to recover damages related to medical expenses, pain and suffering, loss of enjoyment of life, loss of spousal companionship, loss of earnings, loss of earning capacity and more. There may also be an opportunity to receive punitive damages in an amount designed to punish the device manufacturer.

Not only can a lawsuit personally compensate an individual who has been injured by a medical device, it can also send a clear message to the device manufacturer that patient safety is a top concern. Many who go on to file products liability lawsuits hope that their action can help others avoid serious injury in the future.

If you’d like more information on filing a lawsuit over a fracture caused by the device that is the target of the recent shoulder replacement recall, you may benefit from a free case review conducted by an experienced attorney. Your case can be reviewed at no charge, and if you are eligible, a lawyer can discuss your legal options with you.