The last few years have not been good ones for medical device manufacturer Zimmer Biomet. Back in 2008, a component of its hip replacement product, the Alumina Ceramic Femoral Head, was subject to a Class 2 recall when it was discovered that the ceramic head was prone to failure.
More recently, the company’s Comprehensive Reverse Shoulder System has come under FDA scrutiny. Subject to a Class 1 recall (conducted when the product in question may cause “serious adverse health consequences or death”), the Reverse Shoulder System has a high rate of fracturing, requiring risky revision surgery. Consequences can include loss of the use of the shoulder and even death.
But it hasn’t ended there: this week, Zimmer Biomet announced yet another Class 1 recall – this time, of a device known as an Implantable Spinal Fusion Stimulator. The specific models being subject to recall are the SpF PLUS-Mini and SpF XL IIb Implantable Spinal Fusion Stimulators.
These devices are implanted in the surgical patient’s back and provides electrical stimulation over a six month period in order to encourage the joining of two or more vertebrae together (the procedure is known as a posterolateral fusion). According to the company website, the device has a “proven clinical history” with “over 100,000 implanted to date.” Zimmer Biomet also touts the product as “economical” and “cost-effective.”
So – what’s gone wrong?
According to the FDA announcement, these spinal fusion stimulators release “higher than allowed levels of potential [sic] harmful chemicals that may be toxic to tissues and organs.” Patients may require revision surgery, and face the risk of permanent paralysis and even death. This hazard came to light during the manufacturer’s routine testing.
Currently, the recall effects 33 devices that were manufactured between October 11, 2016 and January 18 of this year, and were distributed between March 28 and April 6. Zimmer Biomet has issued an Urgent Medical Device Removal notification, advising hospitals to quarantine the devices and closely monitor patients who have received the implant.
It is worth noting that, like the Alumina Ceramic Femoral Head and the Comprehensive Reverse Shoulder System, the SpF Implantable Spinal Fusion Stimulators were approved through the now-infamous 510(k) Pre-market Clearance process, which allows companies such as Zimmer Biomet to bypass normally stringent testing and clinical trials when they can demonstrate that the product is “substantially similar” to one that has already been approved and is on the market.
The number of harmful medical devices and medications that have been allowed on pharmacy shelves and in hospitals has gotten long enough to fill a book – and there is no end in sight. Hopefully, the problem with Zimmer Biomet’s spinal fusion stimulators has been caught in time to avoid unnecessary pain and suffering – but with a 100,000 of them now implanted in patients, there is no guarantee that many people won’t be hurt. In that case, Zimmer Biomet’s corporate defense lawyers will have yet another round of litigation heading their way, and plenty of employment security for years to come.
It seems that corporate “people” never learn their lessons.