Beware: Use of Zimmer Biomet’s Comprehensive Reverse Shoulder System Humeral Tray may Cause Permanent Loss of Shoulder Function, Infection or Death
According to the Agency for Healthcare Research and Quality, there are about 53,000 individuals in the U.S. who go through a shoulder replacement surgery every year. Shoulder replacement surgery is a popular corrective solution for those suffering from extreme joint pain or a limited range of shoulder motion; it is also performed to relieve patients of the pains caused by different forms of arthritis. Doctors, however, only consider this if medication and other non-surgical treatments can no solve shoulder problems complained of by patients.
Unfortunately, not all shoulder replacement surgical procedures turn out safe and effective as manufacturers promise. This is due to defectively designed replacement implants. Thus, instead of the guaranteed increased function of the shoulder and minimized pain, patients, who are implanted with a defective device, end up suffering from worse pain besides necessitating corrective surgery.
There are different types shoulder replacement procedures. The type of surgical procedure a patient needs to undergo will depend on his/her doctor’s evaluation of his/her specific situation and health needs. One of these procedures is the Reverse Total Shoulder Replacement or Reverse Total Shoulder Arthroplasty, while the device commonly used for this replacement surgical procedure is the Comprehensive Reverse Shoulder System Humeral Tray that is manufactured by Zimmer Biomet.
This Zimmer Biomet device is implanted in patients who suffer from rotator cuff tears and in those who have developed a form of arthritis called arthropathy. The device is also prescribed and implanted in those who had previous shoulder replacement surgeries that were unsuccessful. The comprehensive reverse shoulder device is surgically implanted and was designed to help restore arm movement.
According to Zimmer Biomet shoulder lawsuit lawyers, Zimmer Biomet was forced to issue a recall on more than 3,600 of its Comprehensive Reverse Shoulder System Humeral due to increasing reports of device failure, specifically fracturing. The fracture rate of the devices is said to be significantly higher than the rate stated in the product’s labeling. Zimmer Biomet issued this recall on December 15, 2016. According to the U.S. Food and Drug Administration (FDA), these fractures can possibly result in revision surgeries, which could cause serious adverse health consequences, such as permanent loss of shoulder function, infection or even death.