Biomet, Inc. agreed to pay $350,000 to a Denver man who had both shoulders replaced with defective Comprehensive Reverse Shoulder prostheses, only to have double revision surgeries after they both snapped and broke inside his body.
Plaintiff Alfonso A. Alarid accepted the settlement on Feb. 4, 2016, from defendants Biomet Inc., Biomet Orthopedics LLC and Biomet Manufacturing LLC, all based in Indiana. The case is Alarid v. Biomet, Case No. 1:14-cv-02667-REB-NYW, US District Court for the District of Colorado.
The settlement was negotiated by plaintiff’s attorneys Jennifer E. Bisset, Bisset Law Firm of Denver, CO, and Gregory A. Hall, Law Office of Gregory A. Hall of Denver, CO.
On September 13, 2010 Biomet issued a recall notice for the defective Comprehensive Reverse Shoulder, including the two Comprehensive Reverse Shoulder devices that were implanted into the plaintiff’s left shoulder in 2009 and his right shoulder in 2010. According to Biomet, it issued the recall notice due to complaints it received about fracturing of the device at the joint between the trunnion and the baseplate.
Biomet’s Comprehensive® Reverse Shoulder is a Class II medical device, approved in 2008 pursuant to the FDA short-cut 510(K) process, instead of the more rigorous FDA “Premarket Approval” process. By September 2010 Biomet had received multiple adverse reports about the defective Reverse Shoulder and recalled it.
Alarid filed suit on July 20, 2014, alleging strict products liability, breach of express warranty, breach of implied warranty of merchantability and negligence.
Left shoulder replaced
His doctor told him on October 21, 2008, that he would need a left shoulder replacement because of a massive rotator cuff tear. Reverse shoulder replacement, or RTSA, is a surgical procedure that reverses the anatomy of the shoulder. 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.
Alarid had the left shoulder replaced on September 24, 2009. On July 30, 2012 Plaintiff was simply participating in physical therapy when he felt a clicking sensation in his left arm followed by immediate pain. A CT scan on August 6, 2012 showed that the humeral baseplate tray and trunnion of the Biomet Comprehensive® Reverse Shoulder had separated. On October 11, 2012, Dr. Schneider performed revision surgery to remove and replace the Biomet shoulder prosthesis.
A visual inspection confirmed that the device fractured at the joint between the trunnion and the baseplate.
Right shoulder replaced
On May 12, 2010 an MRI of Plaintiff’s right shoulder showed severe glenohumeral joint arthritis with labral tearing and irregularity with a large paralabral cyst along the posterior glenoid. On July 22, 2010, Plaintiff underwent surgery on his right shoulder, during which Dr. Schneider performed a reverse right total shoulder arthroplasty and implanted the second Biomet Comprehensive® Reverse Shoulder device.
On March 22, 2013, the plaintiff was simply getting up off the floor when he experienced right shoulder pain. On April 17, 2013, Dr. Schneider performed revision surgery on the right shoulder to remove and replace the defective Comprehensive® Reverse Shoulder prosthesis.
A visual inspection confirmed the device fractured at the joint between the trunnion and the baseplate, and that the trunnion had snapped off.