Did Cutting-Edge Stryker Process Cut Plaintiff the Wrong Way?

Lafayette, LAOne could understand Ouita Corley’s frustration with her knee replacement surgery, an operation that has been performed hundreds of thousands of times. But what sets Corley apart from other knee replacement patients, is the use of Stryker ShapeMatch Cutting Guide in her procedure. The device has since been recalled, and Corley now serves as a plaintiff in a ShapeMatch Cutting Guide lawsuit.

According to Corley’s knee replacement lawsuit, the ShapeMatch Cutting Guide is individualized for the patient, based on three-dimensional imaging derived from MRI or CT scans. ShapeMatch, which is part of Stryker’s Triathlon Knee implant system, in turn produces a customized surgical plan for each patient based on proprietary 3D imaging software.

Corley’s knee replacement lawsuit notes that a knee replacement procedure utilizing the Stryker ShapeMatch Cutting Guide system was performed at Lafayette General Hospital in Lafayette, Louisiana, on March 30, 2009. Following her procedure, the plaintiff alleges she began experiencing significant knee pain and discomfort, with joint instability and limited mobility. Diagnostic testing has revealed that the knee replacement is misaligned and may need to be replaced.

The allegation is that due to a software error in the Stryker ShapeMatch Cutting Guide system, the particular guide designed for the plaintiff’s knee was misaligned and found to be in an error state for the plaintiff’s particular physiology. The US Food and Drug Administration (FDA), four years following Corley’s surgery, issued a health alert and a recall of the device based on reports that due to a software defect, “the parameters of the manufactured cutting guides may not meet the surgeon’s pre-operative planning parameters entered via the web application,” states court documents inherent with the knee replacement lawsuit.

“Additionally, Stryker Corporation through their Stryker Orthopaedics division determined that another software defect resulted in the displayed parameters (e.g., depth of resection angle of cut) not matching the cutting guides produced,” according to the lawsuit, which alleges Stryker Triathlon Knee implant injury.

The ShapeMatch Cutting Guide lawsuit notes that the ShapeMatch Cutting Guide has not been on the market since November 2012. The FDA formally issued a Class 1 recall of the system in April 2013, due to a software defect that results in wider cutting ranges.

Hip and knee replacement failures have been on the upswing in recent years, as new materials and technology are introduced as a means to extend the life of a replacement knee and hip - historically, upwards of 15 years with normal use. However, problems with various designs and materials, such as metal-on-metal hips, have had the opposite effect by way of severely reducing the lifespan of the product, requiring patients to endure replacement knee and hip surgery within a few years, or even within months of their initial procedure.

Part of the problem, according to various critics and many a knee replacement lawsuit, is a fast-track approval process observed by the FDA that allows new medical devices with design characteristics essentially similar to existing devices, to bypass traditional vetting involving clinical trials. This brings the products to market more quickly, providing patients with an opportunity to benefit from the new device or updated design sooner. It also spares the manufacturer from the expense and delays required of clinical trials, and allows for the introduction of a new revenue stream for the manufacturer, derived from the new product, that much sooner.

The downside to this fast-track approval process, say the critics, is that patients acquiring untested and unproven technology serve as guinea pigs. Given a spate of hip and knee replacement failures, this is proving to be the case.

According to the lawsuit, Corley has endured Stryker Triathlon Knee Implant pain, “and has suffered, and continues to suffer, both injuries and damages including, but not limited to, past, present and future physical and mental pain and suffering; and past, present and future medical, hospital, rehabilitative and pharmaceutical expenses, and other related charges,” according to her ShapeMatch Cutting Guide lawsuit.

The lawsuit is Corley v. Stryker Corp et al, Case No. 6:2013cv02571. The action was filed August 29, 2013, at Louisiana Western District Court, Lafayette Office, County of Lafayette. District Court Judge Rebecca F. Doherty has been assigned to the case.