In 2008, Zimmer's Alumina Ceramic Femoral Head – a component of the company's artificial hip replacement – was the target of a Class 2 recall by the FDA. According to the manufacturer, the device was recalled because “when used with cobalt/chromium hip stems, the average test values for ceramic head bursting falls below the guidance document limits if the taper is made by casting instead of by forging.” Less than a decade later, another Zimmer Biomet product has been demonstrated to be defective. This time, it is the Comprehensive Reverse Shoulder implant, which has been subject to a Class 1 recall.
The FDA issues a Class 1 recall only in the most extreme cases, when a product has the potential to cause serious injury or even death. The Zimmer shoulder replacement has a high fracture rate. When this happens, revision surgery is required. This surgery is extremely risky, and can cause the patient to lose use of the shoulder. For some patients, it can even be fatal.
According to Zimmer, the “Anatomical Shoulder™ Inverse/Reverse System” was designed to restore arm movement to patients who suffered from an injury to the rotator cuff, known as “cuff tear arthropathy,” because of arthritis – and for whom standard surgical procedures had failed. Like the Alumina Ceramic Femoral Head, the Reverse Shoulder product won FDA approval through the infamous 510(k) Pre-Market Approval process, which allows a manufacturer to bring a product to market if it can be demonstrated that said product is “substantially similar” to an existing product already being sold and distributed.
It seemed like a good idea at the time. Unlike a standard shoulder replacement, the Zimmer Reverse Shoulder System was the opposite of the patient's natural shoulder anatomy, bypassing the damaged rotator cuff and relying on the deltoid muscle for movement. However, as was the case with the artificial hip product, the Biomet Comprehensive Reverse Shoulder Humeral was prone to a “higher than anticipated rate of fracturing due to design.” Specifically, the recall applies to the Tray Model 115340, a total of 3,662 units of which were manufactured between August 25, 2008 and September 27, 2011.
This is not the first time there have been problems with Zimmer's Reverse Shoulder System. In 2010, the FDA issued a recall for the Biomet Comprehensive Reverse Shoulder Humeral Tray with Locking Ring. In 2015, there was yet another recall for the Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adaptor – because the taper adaptor itself was not included in the packaging, resulting in surgical delays of 30 minutes or more.
It appears that Zimmer Biomet has been extremely careless in its rush to get its products into the hands of surgeons, particularly since shoulder replacements represent the third largest market in joint replacement surgery worldwide – a market that is expected to grow with an aging population and an increase in patients suffering from rheumatoid and osteoarthritis. Demand for reverse shoulder arthroplasty is projected to grow by over 12% by 2020 – and it seems that Zimmer was willing to sacrifice patient safety in order to get in on those sales.