The U.S. Food and Drug Administration has determined that a previously-recalled device used for surgical knee replacement is likely to cause serious health problems.
Our product liability lawyers understand that the manufacturer, Stryker Corp., had initially issued a voluntary recall in January, but now the FDA has reclassified it is a Class I recall.
A Class I recall is the most severe designation that can be given, purporting that use of the product is accompanied by a high risk potential for serious injury or death. Class I recalls are fairly uncommon in the U.S., reserved only for the most serious situations.
The ShapeMatch Cutting Guides were tools used by surgeons that were supposed to help surgeons with the positioning of the components of the knee replacement, as well as to guide the marking of the bone prior to cutting.
Back in November, the company sent a message to all surgeons registered with the company to cease their orders. A voluntary recall came three months later, with the firm explaining at that time that a number of the devices could have been improperly manufactured.
The firm admits that problems with the devices had been reported soon after the ShapeMatch Cutting Guides hit the market. Among problems identified was that patients who had been implanted with the device complained of failure, meaning they had to undergo a potentially risky revision surgery to have the situation corrected or the device replaced.
Stryker had initially advised only routine care for patient follow-ups. Now, patients whose surgeons used this product should contact their surgeon, especially if they have been experiencing pain, numbness or other adverse effects.
The recall won't affect other Stryker products, such as the Triathlon Knee System or the Triathlon standard instrumentation.
Still, we would advise anyone who has undergone a procedure with a Stryker product to keep a watchful eye on the overall condition. News of this development with ShapeMatch was somewhat unsurprising, given Stryker's history. In March, the FDA received a series of additional injury and death reports regarding the firm's surgical waste management system, called Neptune. The two different components of the system essentially act as a vacuum to suction fluid from patients in the midst of a procedure. However, these devices ended up being recalled last year, after the FDA received word that one patient died and another was injured after the suction was improperly applied.
Stryker is also the manufacturer of the Rejuvenate hip replacement device. As you may recall, this product has been found responsible for increased rates of metallosis in patients. This is a condition involving the build-up of metal debris in the body's soft tissue. The Rejuvenate product has also been linked to a high rate of early failure, meaning many patients have had to undergo additional corrective surgery to have the faulty device replaced.
Patients with questions about the ShapeMatch Class 1 recall may also call Stryker directly at 1-888-STRYKER from 8 a.m. to 8 p.m. EDT Monday through Friday. For those who have suffered ill effects, we would also advise contacting an experienced product liability law firm.