The Zimmer Biomet recall of its Comprehensive Reverse Shoulder implant has caused major concern in the medical community, with many patients filing legal action against the medical device manufacturer. The FDA categorized the Zimmer Biomet as Class I, which is reserved for problems that could lead to serious injury or death.

The Zimmer Biomet recall affects the company’s Comprehensive Reverse Shoulder implant, due to reports linking it to fractures more frequently than stated on the label. Device fractures will likely force patients to undergo revision surgery to correct any damage, and possibly a second revision surgery to remove or replace the implant.

These revision surgeries “could cause serious adverse health consequences such as permanent loss of shoulder function, infection, or rarely, death.” Zimmer Biomet had sent out an Urgent Medical Device Recall Notice and Certificate of Acknowledgment on Dec. 20, 2016 to healthcare facilities, requesting that they “identify and quarantine any affected devices in stock.”

The Zimmer Biomet recall affects 3,662 reverse shoulder implants manufactured from Aug. 25, 2008 to Sept. 27, 2011, and distributed between October 2008 and September 2015.

The Zimmer Biomet recall did not recommend any particular follow up care for patients who had the Comprehensive Reverse Shoulder implanted, and instead instructed surgeons to simply use current follow up procedure care for these patients.

Overview of Zimmer Biomet Reverse Shoulder Problems

The Comprehensive Reverse Shoulder implant is typically prescribed to patients suffering from significant shoulder damage or arthritis and who cannot use traditional shoulder replacement implants.

These shoulder replacement implants are typically prescribed to patients who have torn their rotator cuffs and developed serious arthropathy, or patients who have had shoulder replacements fail in the past due to rotator cuff deficiency. This is because the tendons are too badly damaged for traditional shoulder replacement implants.

Reverse shoulder replacement implants attach the ball-shaped component to the socket side of the joint, which is opposite of where the head of the arm bone goes naturally. Even though reverse shoulder replacement implants are good alternative, these procedures can potentially result in shoulder replacement fractures.

These reverse shoulder replacement fractures normally occur during the implant surgery, when the surgeon is getting the bone ready for the implant. Patients who experience fractures from reverse shoulder replacement implants may have to undergo revision surgery and may be at risk for surgical complications including:

• Permanent damage to shoulder function
• Shoulder area becomes infected
• Death

According to a study published in the Journal of Shoulder and Elbow Surgery, patients who suffered a fracture after shoulder replacement surgery “had a 6 times higher incidence of death within 30 days than the general population.” Reported fatalities were linked to several blood clot and abdominal complications.

Even though the Zimmer Biomet recall prevents further incidents of reverse shoulder implant fractures, it does not help patients who have already suffered complications. Patients who have experienced reverse shoulder implant problems may be able to take legal action against Zimmer Biomet.