In other words, things didn’t work out as many had hoped. Optimism trumped by reality. But also, as is witnessed by this case (akin to various other medical devices), part of the problem lay with the promise of a good idea not properly vetted through dedicated clinical testing.
The Stryker ShapeMatch Cutting Guide was software-based and designed to assist in pre-operative planning of knee replacement. The idea was to derive a three-dimensional model of a patient’s knee from images obtained through an MRI or CT scan, followed by the use of the ShapeMatch Cutting Guide to select the various device components that best fit the unique anatomy of the patient. Such customization was intended to result in even smaller incisions, fewer complications and faster healing. The benefit for the hospital, of course, is the ability to free up a bed even sooner than standard arthroscopic procedures might otherwise allow.
But for some patients currently serving as plaintiffs in Stryker ShapeMatch Cutting Guide lawsuits, things have not gone quite so smoothly. According to various reports, a software defect in the ShapeMatch system affected the customized cutting parameters that were found not to align with the cutting guides produced.
Stryker Corporation was originally bullish on the new technology when it received 510(k) clearance from the US Food and Drug Administration (FDA) in May 2011. 510(k) is the so-called fast-track approval process that excuses a medical device manufacturer from the need for extensive and costly clinical trials in order to conclusively test a device on selected trial participants before introduction to the wider population. The thinking behind 510(k) holds that knee replacements are already a medically established procedure, thus updates to existing procedures and technology do not require clinical trials, and can therefore circumvent the kind of vetting reserved for new products and technology.
Eighteen months later, in November 2012, Stryker communicated to surgeons that they should immediately discontinue the use of the ShapeMatch Cutting Guide, and hold off ordering any more units. In January 2013, Stryker issued a voluntary recall of the ShapeMatch Cutting Guide system due to Stryker Triathlon Knee Implant injury. While no fault was found with the Stryker Triathlon Knee system itself, or any of the components involved, the fault was found to stem from the cutting guide system that allowed for errors in cutting parameters and individualized component selection. Thus, the reason for Stryker Triathlon Knee Implant injury has everything to do with the ShapeMatch Cutting Guide System, and nothing to do with the Triathlon Knee Implant itself.
There were also examples of cutting guides that were not properly manufactured within the specifications of the original 510(k) clearance guidelines.
For its part the FDA reviewed Stryker’s voluntary recall and ultimately determined the action as a Class I recall, the most serious classification. The FDA, while not commenting on the approval status of the Stryker ShapeMatch Cutting Guide as a 510(k) clearance approval, announced the Class I recall status on April 10 of last year by way of a press release from Stryker, which the FDA posted on its official FDA website.
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Plaintiffs observe that more traditional procedures were much more invasive and required more healing time. But while more traditional surgery is subject to wider complications, traditional knee replacement was found to have a greater potential for success and the realization of the full life expectancy of the joint, rather than early failure.
Hip and knee replacement failures have been found to increase with newer components and surgical techniques, plaintiffs allege. The FDA has received 44 reports of implant failure as of April 2013.