ShapeMatch Cutting Guide Lawsuit(s) a Non-Issue in Stryker’s Q4

Kalamazoo, MIWhen Stryker did an about-face on its troubled ShapeMatch Cutting Guide in November 2012 after only 18 months, the medical device company said at the time that patients who had undergone knee replacement utilizing the recalled guides would not require follow-up “beyond the routine standard of care.” However, plaintiffs having filed a ShapeMatch Cutting Guide lawsuit, beg to disagree with that statement.

Plaintiff Ouita Corley, who filed her knee replacement lawsuit this past August [Corley v. Stryker Corporation, Case No. 6:13-cv-02571, US District Court, Western District of Louisiana], will likely need revision surgery to replace her allegedly mis-aligned knee. Corley, according to court documents, has encountered pain, mobility issues and instability with regard to her Triathlon Knee implant and expects to require another surgical procedure, together with additional time in the hospital and associated costs.

It should be noted that the allegedly problematic ShapeMatch Cutting Guides, designed to work with Stryker’s Triathlon Knee implant, do not adversely affect the Triathlon Knee implant itself. In fact, participants in Stryker’s Q4 conference call in mid-January were bullish about the performance of their knee division, in spite of the absence (since January 2013) of ShapeMatch.

“Clearly, we are happy with our fourth-quarter performance,” said Kevin Lobo, President and CEO of Stryker, in comments made January 22, 2014. “There were a lot of expectations that our knee business would be under stress with competitive launches and having to overcome not having ShapeMatch on the market. Certainly, our knee has been a very, very well-chronicled knee with very, very low complication rates, with very, very low revision rates, and our sales force has done a terrific job, so we’re certainly growing at least with the market and we feel very good about our performance.”

There were a few other references to ShapeMatch throughout Stryker’s Q4 conference call, but only in the context that ShapeMatch was no longer on the market. There were no references to failures, nor any suggestion that ShapeMatch was potentially defective. References to ShapeMatch, in general, were minimal.


What a difference 18 months makes…

This, in stark contrast to Stryker’s May 2011 announcement of FDA approval for the ShapeMatch Cutting Guide through 510(k) clearance, an approval shortcut maintained by the US Food and Drug Administration and allowable when a device is found to be substantially similar to a previous device and can be marketed safely.

Stryker welcomed the granting of 510(k) clearance with a glowing statement reflecting the advantages of the ShapeMatch system to an ever-increasing market for hip and knee replacements.

“Long-term demand for total knee surgery in the U.S. has been projected to continue increasing from [500,000] procedures in 2005 to 3.48 million procedures in 2030...The ability to contain costs and increase nonoperative time efficiencies is important in meeting the demand for total knee surgery well into the future,” the company said in May 2011.

Within 18 months, Stryker was instructing surgeons to stop using the ShapeMatch Cutting Guide, and to refrain from ordering any more units of the customized cutting guides. The company formally recalled the ShapeMatch Cutting Guides in January 2013.

The FDA responded three months later with a Class I recall of the product. A Class I recall (often referenced as a “Class 1 recall”), the most serious of recalls in the FDA response roster, is reflective of “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”

In response to the issuance of the FDA Class I recall, Stryker issued a statement. “A product notification was issued to surgeons and hospital risk managers, which described the known hazards and harms potentially associated with the use of the affected products, which could result in a knee not functioning properly,” the company said on April 10, 2013.

We’re approaching the one-year anniversary of that statement.

ShapeMatch Cutting Guides approved through FDA 510(k) clearance

The ShapeMatch Cutting Guides were designed to be customized for each patient based on a surgeon’s pre-surgery planning parameters. Once in place, the guide was designed to achieve more efficient and precise cutting of bone in order to place the Triathlon Knee implants. However, it was found, potentially due to a software glitch, that the customized cutting guides were not manufactured to the surgeon’s specifications for the individual patient.

Thus, the implant could be misaligned, causing Stryker Triathlon Knee implant pain, and other issues pertaining to mobility and stability, for the patient.

Hip and knee replacement failures have been on the upswing since new products, many touting new materials and designs, were introduced to the market by way of FDA 510(k) clearance, but have failed up to live up to performance expectations.

Many a knee replacement lawsuit has grown from such failures.

There was no reference in Stryker’s Q4 conference call with regard to improving the design of ShapeMatch and bringing the product back following further testing. There was also no reference to pending litigation stemming from ShapeMatch Cutting Guide lawsuit activity.