Zimmer Biomet issued a voluntary recall of its 3,662 Comprehensive Reverse Shoulder implants on Dec. 15, 2016, distributed during the years 2008 to 2015. The medical products company has since asked for healthcare providers to remove all reverse total shoulder replacement products affected by the recall from their shelves and to return them to the company.

The FDA has categorized this recall as Class 1, which means these products have been linked to serious complications and even death.

This is not the first time Zimmer Biomet has had issues with their reverse total shoulder replacement products. An earlier reverse shoulder replacement recall ran from 2010 through 2012. Another recall was conducted in 2015, in which the Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adaptor.

The current recall affects the Biomet Comprehensive Reverse Shoulder Humeral Tray with Locking Ring.

Overview of Biomet Shoulder Replacement Complications

Reverse shoulder replacements are meant to help restore shoulder function and motion. The Biomet reverse total shoulder replacement is often prescribed to patients who experienced severe rotator cuff injuries or degenerative arthritis.

These products attach the ball of the ball-and-socket joint to the shoulder’s socket side, which is the opposite side of where the ball naturally is. Most fractures reported in conjunction with the Biomet reverse shoulder replacement occurred when surgeons were prepping the bones for implant.

Patients who have received a Biomet reverse shoulder replacement are encouraged to follow up with their doctors, for any potential complications. However, patients did not receive any other follow up instructions after the recall was announced.

According to a recent study published in the Journal of Shoulder and Elbow Surgery, patients who experience fracture during shoulder replacement surgery are six times more likely to face death within 30 days, compared to the general population.

The causes of death in association with reverse shoulder replacement surgery include cardiac complications and abdominal problems. The 2016 Biomet reverse total shoulder replacement recall was issued due to injury reports indicating that the rates of fractures occurring during the implant surgery were higher than stated on the product’s label.

These fractures can cause the device to break, allow metal ions to seep into the blood, and can result in permanent loss of shoulder function. Often, patients have to undergo revision surgery, which is riskier than the initial implant surgery.

Patients who have suffered complications from the Biomet reverse total shoulder replacement may be eligible for compensation. Potential claimants should contact a knowledgeable medical device lawyer to determine eligibility for a Biomet shoulder replacement lawsuit.