As reported by Mass Device, medical manufacturer Zimmer Biomet is the subject of a recall issued by the Food and Drug Administration (FDA). This recall affects the company’s shoulder replacement implants, which have been the target of consumer complaints involving shoulder fractures, pain, infections, permanent shoulder function loss, and other injuries. The FDA is labeling this as a Class 1 action, which means the agency believes there is a probability the product will cause death or have a serious negative impact on the user’s health.
The device in question was a surgical implant meant to restore arm movement in people with torn rotator cuffs, arthritis in the shoulders and those who have already had shoulder implants that have failed. For these types of patients, traditional shoulder replacement wasn’t an option because the surgery required could lead to limited motion and pain. These devices used a reverse total shoulder placement method, which has the deltoid muscle positioning and powering the arm instead of the rotator cuff.
Zimmer Biomet sent out an urgent notice about the recall to its hospitals and doctors back in December of 2016. The recall itself affects 3,662 of the company’s Comprehensive Reverse Shoulder Humeral product from all lots with the part number 115340. These recalled devices were made from August of 2008 to September of 2011 and distributed between October of 2008 and September of 2015. It should be noted that this product was approved by the FDA for sale in 2008 through the fast-track program, which allows makers to skip human clinical trials if they can show that their device is similar enough to another device that was already approved by the agency.
Unfortunately for all the patients affected by this recalls and others, this is not the first time a shoulder product from the Indiana-based manufacturer has been recalled. Back in September of 2010, Biomet had to recall its shoulder humeral tray with locking ring after receiving complaints that the device was splitting right at the joint between the baseplate and trunnion. Then, in April of 2011, another recall impacting a custom shoulder humeral tray was announced as those devices may have had a locking ring that wasn’t assembled properly. This fast-track process has been the focus of some criticism, with Fortune reporting that some companies are buying vouchers that allow for a review for inclusion in the sped-up process.
Shoulder devices from Biomet have already been the focus of lawsuits from injured patients. As reported by Lexis Legal News, Colorado resident Alfonse Alarid settled a case against Biomet and received $350,000 in damages for his failed shoulder implants from the company. As a result of the device failure, Alarid had to endure revision surgery and pain to remove and replace the defective devices.
If you or someone you love has been harmed by any sort of defective product, you may be entitled to legal compensation for your pain, loss of life quality, suffering and other losses associated with the faulty product. Speak to an experienced defective product injury lawyer today to protect your rights.