Zimmer Biomet is recalling a component of its Biomet comprehensive shoulder system, following reports of a high rate of fractures.

This shoulder implant system is designed for use in patients with particularly severe shoulder problems. Fractures in these implants can make things even worse for such patients, putting them at risk for complications like infection, permanent loss of shoulder function, or possibly death.

According to a February 2017 recall announcement by the FDA, the recall was issued because the Zimmer Biomet comprehensive shoulder system has been fracturing at a rate higher than that stated on the device’s labeling.

The Biomet comprehensive shoulder system is a surgically-implantable device used for shoulder replacement. It’s intended for use in patients with significantly large rotator cuff tears who have developed a severe type of arthritis known as cuff tear arthropathy, and for whom previous shoulder replacements have failed.

The difference between traditional and reverse shoulder replacement starts with where the ball and socket implants are placed. In traditional shoulder replacement, these implants take the place of the naturally-occurring ball and socket components of the original joint, with the ball at the top of the arm bone and the socket implanted inside the shoulder.

In a reverse shoulder replacement, the ball and socket components switch places. The ball is implanted in the shoulder and the socket in the top end of the arm bone. This rearrangement allows the deltoid muscle to take over the duty of arm movement from the rotator cuff.

For patients with cuff tear arthropathy, a traditional shoulder replacement could leave them with pain and limitation of motion. A reverse shoulder replacement is intended to restore arm movement for these patients without burdening the damaged rotator cuff.

Zimmer Biomet issued the recall effective December 2016. The specific component affected by the recall is the Biomet Comprehensive Reverse Shoulder System Humeral Tray Model 115340. The recall affects more than 3,600 units manufactured between August 2008 and September 2011.

The Biomet Comprehensive Shoulder System

This Biomet comprehensive shoulder system has been available for use since it was first approved by the FDA in 2008.

The FDA approved this system under the expedited 510(k) approval process. This process allows for quick approval of new medical devices without more rigorous clinical studies and testing as long as the device’s proponent can show it is substantially similar to some other medical device already on the market.

Other Biomet shoulder replacement components have also been subject to recall within the past several years. The company recalled certain reverse shoulder humeral trays in April 2011 due to an incorrectly assembled locking ring.

And in September 2010, Biomet recalled another category of humeral trays in response to reports that the device might fracture at the joint where the trunnion meets the baseplate.

These two older recalls were designated by the FDA as Class II, meaning the problems with these products could cause temporary or medically reversible adverse health consequences.

The current recall, however, is designated as Class I. This designation means the FDA believes the relevant problem could result in serious injuries or death. The complications associated with this device may require affected patients to undergo revision surgery, exposing them to a whole new set of complication risks.