Zimmer Biomet has issued a recent Zimmer shoulder replacement recall, due to injury reports indicating a high fracture rate. The Zimmer shoulder replacement recall primarily focuses on the Comprehensive Reverse Shoulder replacement system, after numerous patients suffered serious complications.

The problems reported range from limited range of motion to death. Many patients have had to undergo revision surgery to fix their complications. The Comprehensive Reverse Shoulder has been largely associated with unexpected fractures, which can lead to permanent loss of shoulder movement, infection, and even death.

The Comprehensive Reverse Shoulder replacement is typically implanted to help restore arm movements that may have been lost due to injury or disease. Most often, this device is prescribed to patients with torn rotator cuffs with severe arthritis.

In these cases the shoulder replacement implant is needed due to severe damage of the tendons, creating the need for a reverse shoulder replacement rather than a traditional shoulder replacement. Reverse should replacements work by attaching the implant’s head to the socket side of the joint, which is the opposite of where the head occurs naturally.

This essentially means that the natural position of the shoulder is reversed, making the implant surgery a very complex and risky one. Reverse shoulder replacement fractures sometimes occur during the implant surgery itself when the surgeon is preparing the bone for the implant.

Even though this device has helped numerous patients, there have been many injury reports that eventually led to the Zimmer shoulder replacement recall.

Overview of the Zimmer Shoulder Replacement Recall

The FDA announced the Zimmer Shoulder Replacement Recall in February 2017. The recall was issued due to injury reports and recent studies indicating the device may have a higher injury rate of fracture.

The FDA categorized this recall as Class I, which is the most serious type of recall the agency can issue. These categorized recalls are only issued for medical devices linked to serious injury or death.

Zimmer Biomet had issued their own Urgent Medical Device Recall Notice and a Certificate of Acknowledgment to the medical community on Dec. 20, 2016, asking that any remaining Biomet Comprehensive Reverse Shoulder implants not be used and to be removed from the company’s facilities.

The Zimmer Biomet Comprehensive Reverse Should replacement Recall applies to the devices that were distributed between October 2008 and September 2015. Zimmer Biomet advised customers to follow existing follow-up protocols, but offered no recommendations for patients who suffered complications.

Patients who were affected by Zimmer Biomet shoulder replacement complications may be able to file legal action against the manufacturing company.