Medical device manufacturer Zimmer Biomet issued a Zimmer shoulder replacement recall over problems with a high rate of fracture.

The device involved in the Zimmer shoulder replacement recall is the Comprehensive Reverse Shoulder implant. Patients who have suffered from a device fracture may experience the following complications: permanent loss of shoulder function, infection in the shoulder area, and in some extreme cases, even death.

Zimmer Biomet Comprehensive Reverse Shoulder Device

The Zimmer Biomet Comprehensive Reverse Shoulder device was approved by the U.S. Food and Drug Administration (FDA) in 2007. Biomet marketed the device as the “next generation reverse shoulder prosthesis.”

Since then, the Biomet Comprehensive Reverse Shoulder humeral device has been associated with a higher-than-expected rate of fracture, as well as a higher rate of revision surgeries. Revision surgery places a patient at further risk, as well as increases their medical bills.

Zimmer Shoulder Replacement Recall

Zimmer Biomet issued a Zimmer shoulder replacement recall in February 2017, according to the U.S. Food and Drug Administration (FDA). The recall came after reports that the device had a higher rate of fracture than was reported on the product’s label.

The FDA classified the Zimmer shoulder replacement recall as a Class 1. Class 1 recalls are reserved for devices that can cause serious injuries or death. Class 2, by contrast, involves devices that cause temporary injuries.

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.

The Zimmer 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.

The Zimmer shoulder replacement recall affected devices distributed between October 2008 and September 2015, totaling around 3,662 implant devices.

Zimmer Shoulder Replacement Recall Lawsuits

Zimmer Biomet has already begun facing shoulder replacement lawsuits after the Zimmer shoulder replacement recall.

The plaintiff in one such claim alleged that implantation of the Biomet Comprehensive Reverse Shoulder system led to injuries and additional surgeries. Eventually, Zimmer Biomet resolved that claim in February 2016 with a $350,000 settlement.

If you or someone you love has suffered fracture or other injury because of a reverse shoulder replacement surgery with the Biomet Comprehensive Reverse Shoulder Humeral replacement, you may benefit from a consultation with a knowledgeable medical device attorney.

While filing 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.