On February 16, 2017, Zimmer Biomet recalled its Comprehensive Reverse Shoulder System Humeral Tray Model 115340 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.
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.
The 3,662 recalled devices were manufactured between August 25, 2008, and September 7, 2011, and distributed between October 2008 and September 2015. The trade name of the Comprehensive Reverse Shoulder System Humeral Tray Model 115340 is Biomet Comprehensive Reverse Shoulder Humeral. Recalled products carry the product codes KWS or PAO. Affected lot numbers include all lots with part number 115340.
See the FDA Safety Alert
See the Recall
See also Medical Law Perspectives, September 2015 Report: Arthritis Pain and Inflammation: Diagnosis and Treatment Risks
See also Medical Law Perspectives, July 2013 Report: New Hips, New Knees, New Problems: Hip and Knee Replacements
See also Medical Law Perspectives, April 2012 Report: Using Medical Devices Off-Label: False Claims, Overpromotion, Malpractice, and Other Dangerous Territory