Earlier this year, Biomet, Inc. agreed to pay $350,000 to a Colorado man who allegedly experienced the failure of two Comprehensive Reverse Shoulder Replacements. Per his shoulder replacement lawsuit, the failures were allegedly the result of a component that Biomet had recalled in 2010. (Alfonse A. Alarid v. Biomet, Inc., et al., No. 14-2667)
According to documents filed in the U.S. District Court, District of Colorado, the plaintiff underwent a left reverse shoulder replacement with Biomet’s Comprehensive Reverse Shoulder in September 2009. The same device was implanted in his right shoulder in 2010. Reverse shoulder replacement is a surgical procedure that reverses the anatomy of the shoulder. Per the lawsuit, it is designed so that the ball is attached to the shoulder blade (scapula) and the socket is placed on top of the upper -arm bone (humerus). By reversing the normal anatomy, the deltoid muscle, one of the stronger shoulder muscles and the only abducting muscle remaining in the shoulder, is given control to raise the arm.
Within in just a few years of implantation, both shoulders failed at the joint between the trunnion and the baseplate, causing pain and loss of function. As a result, the plaintiff was forced to undergo revision surgery to remove and replace the devices.
According to the complaint, the Biomet Comprehensive Reverse Shoulder was cleared for sale via the U.S. Food & Drug Administration’s 510K protocols in 2008. This process is less stringent than the agency’s premarket approval process, and allows a device to come to market without the benefit of human testing if a manufacturer can demonstrate that it is “substantially equivalent” to a previously-approved product.
The recently-settled lawsuit claims that the prostheses received by the patient were involved in a 2010 Biomet shoulder replacement recall that was enacted due to complaints regarding fracturing of the device at the joint between the trunnion and the baseplate. The complaint further notes that Biomet designed a special tool specifically to remove the trunnion, which would snap off due to the allegedly defective design and manufacture of the Comprehensive Reverse Shoulder.
The lawsuit was scheduled to go to trial in the District of Colorado on February 29, 2016. But according to a February 4th Order, the plaintiff had filed motion that same day requesting an entry of judgment. Per the Order, a judgment was entered in favor of the plaintiff in the amount of $350,000, including attorney fees and costs.