Recalled Stryker ShapeMatch Cutting Guide System Fast-Tracked to Market

Kalamazoo, MIAny ShapeMatch Cutting Guide lawsuit, pundits say, might include reference to a loophole in product testing guidelines long maintained by the US Food and Drug Administration (FDA) and widely derided by critics. To wit, any proposed medical device with a design similar to a product already on the market can bypass the usual clinical trial process and get to market faster.

In so doing, critics have long maintained, patients in the real world simply seeking medical help and having no desire to serve as a clinical trial participant wind up being guinea pigs anyway.

It was on May 24, 2011, that Stryker Orthopaedics, a division of Stryker Corporation, announced the approval of a new device that has, in just two years, proven to be the foundation for many a Stryker Triathlon Knee implant injury.

There is little debate over the need for sound knee replacement options given the aging of the American baby boomer - a point Stryker addressed in its statement. “Long-term demand for total knee surgery in the US has been projected to continue increasing from 0.5 million procedures in 2005 to 3.48 million procedures in 2030. The ability to contain costs and increase non-operative time efficiencies is important in meeting the demand for total knee surgery well into the future,” Stryker said.

The approval of the ShapeMatch Cutting Guide was seen as a means to that end. “ShapeMatch Technology utilizes proprietary 3D imaging software to develop a customized pre-operative surgical plan for each patient,” the statement went on. “Upon surgeon review and approval, this plan is used to develop cutting guides for the individual patient. ShapeMatch Technology is only available for use with Stryker’s Triathlon Knee System, which has demonstrated the best performance among the most frequently used brands of total knee implants as measured by revision rates in the National Joint Registry of England and Wales.”

Less than two years later, Stryker issued a Class I Urgent Medical Device Recall. According to one ShapeMatch Cutting Guide lawsuit, parameters of the manufactured cutting guides did not meet the surgeon’s pre-operative planning parameters entered via web application. It is alleged that another software defect allowed for the display of parameters that failed to match the cutting guides that were produced.

Any attempt by a surgeon to manually adjust the parameters to compensate for the errors resulted in non-compliance with FDA-approved parameters. This left surgeons caught between a rock and a hard place, and patients facing the possibility of not only pain and limited mobility, but also the potential for knee implant revision surgery resulting from a Stryker Triathlon Knee implant injury.

Where does the FDA fast-track approval process come into play? Right from the get-go, when Stryker gushed over achieving FDA 510(k) clearance for the ShapeMatch Cutting Guides system. “We are excited to offer the Triathlon CustomFit Knee with ShapeMatch Technology as a complement to our clinically successful Triathlon knee system,” said Mike Mogul, Group President, Stryker Orthopaedics, in comments couched in the May 24, 2011 statement announcing the ShapeMatch system. “Achieving this clearance is an important milestone for the OtisMed business unit, and it demonstrates our commitment to bringing new, innovative technologies to market that have the potential to improve surgical and operating room efficiencies.”

Had Stryker been denied the 510(k) clearance option and instead been required to conduct lengthy and expensive clinical trials on trial participants aware of the specific risks involved, might this recall and many a ShapeMatch Cutting Guide lawsuit been avoided entirely?

It is interesting to note that the same year that Stryker announced the approval of the ShapeMatch Cutting Guide system, a research paper published by Dr. Diana Zuckerman and Paul Brown of the National Research Center for Women and Families, and Dr. Steven Nissen of the Cleveland Clinic appeared in JAMA Internal Medicine. Their study revealed that most medical devices recalled in the last five years for “serious health problems or death” had been previously approved by the FDA using the less stringent, and cheaper, 510(k) process.

Most patients place their trust in their surgeons, and in the regulatory authority commissioned with the mandate to police the medical device industry and to maintain strict standards. Most assume that a device on the market and actively used has met this criteria. For most busy Americans, finding the time and opportunity to go through a knee replacement procedure, followed by weeks of healing and perhaps physiotherapy, is difficult enough.

To be made to go through all that again within a few years of the initial surgery, potentially impacting a career, the opportunity for promotion or even to earn a living, can be devastating. To have to go through all that because a device was not properly vetted, forms the basis for a knee replacement lawsuit.

Most advocates agree that it’s important to bring promising drugs and devices to market as quickly as prudently possible in order to meet the needs of those most likely to benefit greatly from the new treatment option. However, prudence is the operative word - and critics of the 510(k) clearance option maintain that the opportunity to bring a promising product to market faster without proper vetting, serves to put patient safety at risk while saving a manufacturer the high costs associated with clinical trials, together with the opportunity to begin earning revenue sooner.

Hip and knee replacement failures have been legion in recent years, thanks to the adoption of updated medical devices brought to market through FDA 510(k) clearance.