The FDA has issued a Class I recall, the most serious type of recall, on the Biomet Comprehensive Reverse Shoulder Replacement System.

The Class I recall is warranted because risk of a fracture during implantation is higher than stated in the labeling. Fractures can result in the permanent loss of shoulder function, infection, or even death.

In fact, the Journal of Shoulder and Elbow Surgery reported that patients who experienced a fracture after undergoing shoulder replacement surgery “had a six times higher incidence of death within 30 days than the general population.”

The causes of death in these cases included pulmonary, cardiac, and abdominal issues.

The reverse shoulder replacement systems included in this recall were sold and distributed between October 2008 and September 2015. They were manufactured from August 2008 to September 2011. This recall specifically covers the Zimmer Biomet Comprehensive Reverse Shoulder System Humeral Tray Model 115340.

On Dec. 20, 2016, Zimmer Biomet sent an Urgent Medical Device Recall Notice and a Certificate of Acknowledgement to healthcare providers requesting that any of the shoulder systems in stock be quarantined and removed.

Patients who already received the implants were instructed to continue to follow their current follow-up plans with their doctors.

What Is a Reverse Shoulder Replacement?

Reverse shoulder replacements attach on the socket side of the joint, which is the opposite side of where it sits naturally.

Patients who have experienced previously failing shoulder replacement surgeries and those with a specific type of arthritis known as cuff tear arthropathy are most often recipients of reverse shoulder replacements.

Anyone who has tendons that are excessively damaged can be a candidate for the reverse shoulder replacement surgery, which allows the arm to depend upon the deltoid muscle rather than the rotator cuff.

Reverse Shoulder Replacement Complications

Most reverse shoulder replacement fractures occur as the surgeon is prepping the bone to attach the implant. Zimmer Biomet claims in the recall that such fracture incidents are occurring at a higher than anticipated rate with its Comprehensive Reverse Shoulder system.

Anyone who has had a failed reverse shoulder replacement will face revision surgery. The problem with revision surgery is the bone that needs to be utilized as a stabilizer for the new device has most likely been fractured or damaged as a result of the initial surgery.

On its website, Zimmer Biomet says, “Reverse total shoulder replacement can result in increased stability, strength and range-of-motion in your shoulder joint.”

Investigators are looking into whether Zimmer Biomet was aware of the high possibility of fractures and a higher failure rate, but continued to promote and sell the reverse shoulder replacement system to health care providers and consumers, anyway.

If you have received an implant of the Biomet Comprehensive Reverse Shoulder System and have experienced fractures or other failure, you could be eligible for compensation.