Zimmer Biomet has issued a recall of a shoulder replacement device because the device has been fracturing at a higher than expected rate, which can lead to the need for revision surgery and increase the patient’s risk for serious health consequences such as permanent loss of shoulder function, infection, or, in rare cases, death.
The recall affects 3,662 Zimmer Biomet’s Comprehensive Reverse Shoulder devices. The device is surgically implanted to help restore arm movement. The device is used n patients with conditions should as rotator cuff tears who have developed a severe type of shoulder arthritis known as arthropathy and previously failed shoulder joint replacement.
Affected products include the Comprehensive Reverse Shoulder System Humeral Tray Model 115340, under the trade name Biomet Comprehensive Reverse Shoulder Humeral with the product code KWS, PAO. The recall affects all lots with part number 115340. A full list of lot numbers can be found here. The devices were distributed between October 2008 and September 2015.
Zimmer Biomet has notified its customers of this recall and requested that they quarantine any affected devices for a company representative to remove. There are no specific monitoring instructions for doctors or patients related to this recall that are beyond existing surgical follow up protocol, the company said.
Any adverse events related to the Biomet Comprehensive Shoulder System should be reported to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Source: FDA Safety Alert