Stryker ShapeMatch Cutting Guide Triathlon Knee Implant Injury

Stryker, maker of the ShapeMatch Cutting Guide faces a defective product lawsuit regarding its ShapeMatch device. The Stryker ShapeMatch is used as part of the Stryker Custom Fit knee implant to assist with knee replacement surgery, but has reportedly caused injury to the patient, according to a defective product claim. The Stryker ShapeMatch was the subject of a Class I Urgent Medical Device Recall on April 10, 2013.

Before a patient has Stryker Custom Fit knee replacement surgery utilizing the Stryker ShapeMatch cutting guide, an MRI scan will be done in order to create a 3D image of the patient's knee. Once the 3D image is created, cutting guides are made according to that 3D model of the knee; the cutting guides are then used during the actual knee replacement procedure in order to help the surgeon position the knee components.

If you have had an MRI before knee replacement surgery--in order to create a 3D model of your knee from which cutting guides will be made--your surgeon may have used the Stryker Custom Fit Knee System and Stryker ShapeMatch Cutting Guides. If you were unable to have an MRI, you may have had a 3D knee replacement model created using a CT scan.

The Stryker ShapeMatch Cutting Guide is a surgical device used during total knee replacement surgery to position the knee replacement components and guide bone marking before the bone is cut. According to the US FDA, ShapeMatch Cutting Guides are single-use guides used with the Triathlon Knee System.

The ShapeMatch Cutting Guide was designed to allow surgeons to make smaller incisions in the patient's knee and to customize the surgery to the patient's anatomy. The patient undergoes an MRI of the knee prior to surgery and software is then used to create a three-dimensional knee model. That 3D knee model is used to determine the size and position of the knee implant, and ShapeMatch technology is then used to create customized guides to aid the surgeon in cutting bone and positioning the implant.

A defective product complaint concerning the Stryker ShapeMatch, however, alleges the device was misaligned, which resulted in the knee implant being placed in the wrong position. Issues with the Stryker ShapeMatch Cutting Guide reportedly include displayed parameters on the software not matching the cutting guides that were produced and cutting guide parameters not meeting pre-operative planning parameters for surgery. These issues can result in joint instability, pain, limited mobility and fractures, and may require revision surgery.


On April 10, 2013, Stryker issued a Class I Urgent Medical Device Recall regarding the Stryker ShapeMatch. The company recommended that patients who had knee replacement surgery that involved the ShapeMatch contact their surgeon if they experienced symptoms of problems in their knee.

When it announced the recall, the FDA noted that it had received a total of 44 reports—including 41 malfunctions and three temporary, medically reversible injuries—of incidents linked to the ShapeMatch.

In November 2012, Stryker Orthopaedics e-mailed medical professionals about issues with the cutting guides and informed those professionals that they should stop using the cutting guides until further notice. The Stryker Triathlon Knee System is not subject to the recall.

Stryker Shapematch Cutting Guide Legal Help

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Last updated on May-8-15