The FDA has issued a Class I recall, the most serious type of recall, for more than 3,600 shoulder replacement devices — the Biomet Comprehensive Reverse Shoulder Humeral Tray Model 115340. Use of these devices may cause serious injuries or death.
- Product Description: Comprehensive Reverse Shoulder System Humeral Tray Model 115340
- Product Code: KWS, PAO
- Lot Numbers: All lots with part number 115340
- Distribution Dates: October, 2008 to September, 2015
- Manufacturing Dates: August 25, 2008 to September 27, 2011
- Devices Recalled: 3,662
High fracture rate
The Comprehensive Reverse Shoulder is a shoulder replacement device that is surgically implanted to help restore arm movement. This device is beneficial for patients with rotator cuff tears who have developed a severe type of shoulder arthritis known as arthropathy and previously failed shoulder joint replacement.
Biomet Manufacturing Corp., based in Warsaw, IN, is recalling the Comprehensive Reverse Shoulder because these devices are fracturing at a higher rate than is stated in the labeling. Fractures may result in revision surgeries which could cause serious adverse health consequences such as permanent loss of shoulder function, infection, or rarely, death.
No safety review
The FDA gave Bioment clearance to market the shoulder device through the short-cut 510(k) process, based on its similarity to a previously-approved device — but not a review of its safety or efficacy as would happen in a rigororous premarket approval application (PMA):
- The Biomet Comprehensive® Reverse Shoulder – Mini-Baseplate got 510(k) clearance on January 13, 2012.
- The Comprehensive Reverse Shoulder – Titanium Glenosphere got 510(k) clearance on August 27, 2013.
- The Comprehensive® RS Shoulder System got 510(k) clearance on September 28, 2007.
The previous devices were marketed before the May 28, 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act.
Biomet Settles Comprehensive Lawsuit for $350,000
Biomet agreed to settle a lawsuit involving its Comprehensive Reverse Shoulder System for $350,000 in February 2016 according to the Schmidt National Law Group.
The lawsuit was filed in the U.S. District Court for the District of Colorado by a man who was implanted with two Biomet Comprehensive systems. The devices later fractured and the man had to undergo additional surgeries to remove and replace the failed systems.
The plaintiff sued Biomet for product liability in 2014, and the company agreed to settle those allegations roughly two years later in February 2016.
More than 50,000 Americans undergo shoulder replacement surgery each year to relieve joint pain. There are several types of shoulder replacement surgery, including conventional and reverse shoulder replacement.
Reverse shoulder replacement is performed in patients who have completely torn rotator cuffs or previously failed replacement surgeries. Reverse implants rely on different muscles to move the arm than traditional implants and can help restore some motion to these patients who have lost mobility in their shoulders due to severe pain.
Merely three years after Biomet’s Comprehensive reverse shoulder hit the market, the company initiated a recall of certain components of the system.
In a September 2010 Urgent Medical Device Recall Notice, Biomet said it was pulling at least 45 humeral tray and 45 locking ring components in distribution in eight states. The company said it initiated the recall after receiving complaints that the device was fracturing after being implanted.
The FDA posted the recall in December 2010 and labeled it as class II, meaning use of the device could cause temporary or reversible adverse health consequences. The agency terminated the recall in July 2011, but the FDA-determined cause remains pending on the agency’s website.
The humeral tray and locking ring components were recalled from at least eight states in the U.S., including New York, Virginia, Maryland, Alabama, Colorado, South Dakota, Texas and Oklahoma.