Medical manufacturing company Zimmer Biomet issued a recall of its Comprehensive Reverse Shoulder Replacement, reportedly due to a high fracture rate and numerous injury reports. Numerous patients reportedly experienced reverse shoulder replacement complications that later caused them to need revision surgery.

In February 2017, the FDA announced that Zimmer Biomet issued the recall due to injury reports indicating a high fracture rate. The fracture rate suggested by these reports was higher than the rate reflected on the device’s labeling, the agency said.

Patients and physicians reported serious reverse shoulder replacement complications including:

• Permanent Damage to Shoulder Function and Mobility
• Infection
• Death

The FDA has categorized this recall as Class I. This is the most serious recall category for the FDA, designated for medical products that have either caused serious injuries or death.

A reverse shoulder replacement is sometimes recommended for patients who suffer rotator cuff tears or experience shoulder deterioration from cuff tear arthopathy. In such cases, the tendons in the shoulder may be too damaged for traditional shoulder replacements.

Reverse shoulder replacements earn their name from the way they are attached to the patient’s joint, which is the socket side of the joint and is the opposite of where the joint’s natural position.

The Zimmer Biomet reverse shoulder replacement recall applies to approximately 3,662 Comprehensive Reverse Shoulder System Humeral Tray devices. It applies to models distributed between October 2008 and September 2015.

However, nowhere in the recommendations did it mention any precautions for patients to take, except to adhere to existing follow-up care protocol.

Overview of Reverse Shoulder Replacement Complications

Fractures that occur due to reverse shoulder replacements often occur during the implant surgery, especially when the surgeon is getting the bone ready to receive the shoulder replacement.

According to a recent study published in the Journal of Shoulder and Elbow Surgery, patients who suffered a fracture after undergoing shoulder replacement surgery “had a 6 times higher incidence of death within 30 days than the general population.”

Death from reverse shoulder replacement complications can occur in a number of ways, including cardiac, pulmonary and abdominal complications.

Zimmer Biomet also issued an Urgent Medical Device Recall Notice and Certificate of Acknowledgment to medical professionals on Dec. 20, 2016, requesting that any Biomet Comprehensive Reverse Shoulder devices not be prescribed to patients and removed from their facilities.