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As reported in our February 17th blog post (FDA Announces Zimmer Biomet Shoulder Replacement Recall), the United States Food & Drug Administration (FDA) released information on a Class 1 recall of Zimmer Biomet‘s Comprehensive Reverse Shoulder System. A Class 1 recall is issued when there is “a reasonable probability that use of these products will cause serious adverse health consequences or death.”
Zimmer Biomet recalled a total of 3,662 devices with product codes KWS and PAO and all lots with part number 115340 manufactured between August 25, 2008 and September 27, 2011, and distributed between October 2008 and September 2015. In December 2016, Zimmer Biomet started sending recall notices for the reverse total shoulder implants and informed the medical community how to quarantine and return the devices affected by the recall.
Zimmer Biomet’s Comprehensive Reverse Shoulder system is a shoulder replacement device designed to be surgically implanted to restore arm movement in patients with rotator cuff tears who have developed arthropathy and have failed shoulder joint replacements. In 2007. the FDA approved the Comprehensive Reverse Shoulder by way of its 510(K) expedited device clearance process rather than the typically lengthy and thorough premarket approval process. Though the device had never been tested on a human, Biomet (now Zimmer Biomet) claimed that its Comprehensive Reverse Shoulder System would be the “next generation reverse shoulder prosthesis”. Biomet told the FDA in July 2008 that its device was the equivalent of five different systems on the market at that time. Biomet had made one of the devices and the other four were made by Zimmer (a separate company until it bought Biomet in 2014 for $13.4 billion), Exacttech and Encore Medical.
Subsequently, Zimmer Biomet’s Comprehensive Reverse Shoulder system was found to have a higher fracture rate than what was indicated on the product’s label. The part of the shoulder system that is at high risk of fracturing is the shoulder tray or “base plate”, which is the component that attaches directly to the shoulder blade, and to which the “ball” component is secured. These fractures would often require patients to undergo revision surgeries, which could cause more damage, including permanent loss of their shoulder function, infection from the implantation surgery, or death.
The causes of death in shoulder replacement fracture patients included pulmonary, cardiac, and abdominal complications, according to a study published in the Journal of Shoulder and Elbow Surgery. Researchers found that patients who suffered a fracture after shoulder replacement surgery “had a 6 times higher incidence of death within 30 days than the general population.” Further, the Journal reported that, “Despite advances in technique and implant design, instability after reverse total shoulder arthroplasty remains a challenging postoperative complication … Early instability after reverse total shoulder arthroplasty can be related to inadequate soft tissue, inadequate deltoid tension, malpositioned implants, and/or infection, and outcomes of treatment of early instability are generally poor.”
The Biomet shoulder was first recalled on December 16, 2010 in response to Biomet receiving complaints of fracturing. It was Class II recall, meaning that the device could cause temporary or reversible complications. The affected lot numbers were 216080, 216090, 216100, 551630, 877130, 8877160, 877180 and 877200. Biomet had sent Urgent Medical Device Recall Notices to their distributors and customers stating that the recalled devices should be immediately located, discontinued from use, and shipped back to Biomet. Biomet also sent the notices to implanting surgeons informing them of the recall and instructing them to continue to monitor patients for fracture of the device.
Ironically, on December 14, 2016, Zimmer Biomet issued a statement in response to published reports concerning a recent FDA inspection of a Zimmer Biomet manufacturing facility, disclosing that the FDA had completed an inspection of the legacy Biomet manufacturing site in Warsaw, Indiana. Zimmer Biomet indicated that it developed and was executing a remediation plan to fully address certain regulatory compliance gaps at the legacy Biomet operation in Warsaw cited by the FDA. Of course, Zimmer Biomet “remains confident in the quality, safety and efficacy of all of its products” with the assurance that “[n]o patient safety concerns have been identified with any of the products manufactured at the site.”