The U.S. Food and Drug Administration (FDA) has announced a shoulder implant recall on a Biomet device. The FDA classified this as a Class 1 recall, reserved for devices that can cause serious injuries or death.

Biomet Comprehensive Reverse Shoulder Device

The Biomet Comprehensive Reverse Shoulder device was approved by the FDA in 2007. Biomet marketed the device as the “next generation reverse shoulder prosthesis.”

The Biomet Comprehensive Reverse Shoulder Humeral device has been associated with a high rate of fracture, as well as a high rate of revision surgeries. Revision surgery places a patient at further risk, in addition to increasing their medical bills.

Complications linked with shoulder replacement surgery can have serious implications for thousands of Americans. The procedure is a relatively common one: around 50,000 Americans undergo this surgery each year in order to alleviate joint pain.

2017 Biomet Comprehensive Reverse Shoulder Implant Recall

The U.S. Food and Drug Administration alerted the public about a Class 1 shoulder implant recall of the Biomet Comprehensive Reverse Shoulder System. The shoulder implant recall came after the FDA had received sufficient cause for concern due to patient reports of injuries.

The Biomet device carries with it a high rate of fracture, higher than what the device’s label warned, as well as an increased risk of revision surgery. Indeed, patients have reported experiencing shoulder infection, permanent loss of shoulder function, and in certain extreme cases, death.

Around 3,662 implant devices were affected by this shoulder implant recall.

This is not actually the first shoulder implant recall targeted at the Biomet device. The FDA posted Class II shoulder implant recall information about the device in December 2010. A Class II recall indicates that the device is associated with temporary or reversible complications. This shoulder implant recall was terminated in July 2011.

Biomet Comprehensive Reverse Shoulder Lawsuits

Biomet has already begun facing legal claims over its Biomet Comprehensive Reverse Shoulder system. The plaintiff who filed one such claim alleged that his implantation with two Biomet Comprehensive Reverse Shoulder systems led to device fracture that led to needing additional surgeries.

Because of the device fracture, the plaintiff filed a shoulder replacement lawsuit against Biomet over product liability claims. It took until February 2016 for Biomet to come to a settlement agreement, but the company eventually agreed to a $350,000 settlement in February 2016.

Patients who have suffered complications after implantation of the Biomet Comprehensive Reverse Shoulder system may be able to receive compensation by filing a Biomet lawsuit.

While a lawsuit cannot take away the pain and suffering that such complications cause, it can help to alleviate financial loss felt due to medical expenses, lost wages, and other damages.

If you or someone you love has suffered an injury, most notably a fracture, because of a shoulder replacement surgery with the Biomet Comprehensive Reverse Shoulder Humeral replacement, you may be able to receive compensation by filing a Biomet lawsuit.