What is a Stryker ShapeMatch Cutting Guides?
The ShapeMatch Cutting Guide is a single-use, disposable instrument that was approved in May 2011. It is manufactured by Stryker Orthopedics and is used exclusively with the Triathlon Total Knee System during knee replacement surgery. During the procedure, a patient first undergoes an MRI (magnetic resonance imaging), and a computer creates a 3D image of the patient’s knee. The ShapeMatch software analyzes the MRI and helps a doctor decide where to make bone cuts and choose the correct size, alignment, and position of the Triathlon knee implant.
Stryker Cutting Guide Recall
Unfortunately, there is a software defect with the Stryker ShapeMatch Cutting Guide that may cause a surgeon to make improper bone cuts, resulting in an improperly-fitted knee implant. In April 2013, a Class 1 recall notification was issued by the U.S. Food and Drug Administration (FDA) for Cutting Guides sold between May 2011 and November 2012. People who had knee replacement surgery during this time may be at risk of premature failure of their knee implant and early revision surgery.
Reason for the Recall
The FDA has received a total of 44 reports of incidents related to the Stryker Cutting Guides, including 41 malfunctions and 3 medically-reversible injuries. According to the FDA, they are being recalled due to the following problem:
“The parameters of the manufactured cutting guides did not meet the surgeon’s pre-operative planning parameters entered via the web application. When the parameters were manually edited to compensate for a defect in the existing software, the edits resulted in cutting guides ranges that are not cleared by the FDA. Additionally, Stryker Orthopaedics determined that another software defect resulted in the displayed parameters (e.g. depth of resection, angle of cut) not matching the cutting guides produced.”
Stryker ShapeMatch Lawsuits
One of the first Stryker ShapeMatch Lawsuits was filed in October 2013 in the U.S. District Court for the Western District of Louisiana. The plaintiff, Ouita Corley, underwent total knee replacement surgery in March 2009 in Lafayette. Her surgeon used the ShapeMatch Cutting Guide. Soon afterward, Corley began experiencing pain, discomfort, joint instability, and limited mobility. Tests indicated that her knee replacement was misaligned and would need to be replaced.
Risks & Complications of Stryker Cutting Guide
- Knee instability
- Bone fracture
- Need for revision surgery
- Chronic pain
- Limitations on mobility
- Limping or awkward gait
- Infection (warmth, swelling, inflammation, redness)
- Unusual sounds in the knee (grinding, clicking, popping, etc.)
- Permanent disability
Do I have a Stryker Cutting Guide Class Action Lawsuit?
The Product Liability & Defective Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Stryker ShapeMatch Cutting Guide lawsuits. We are handling individual litigation nationwide and currently accepting new cases in all 50 states.
Free Stryker ShapeMatch Cutting Guide Class Action Lawsuit Evaluation: Again, if you or a loved one was injured by the Stryker ShapeMatch Cutting Guide, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit or by joining a Stryker ShapeMatch Cutting Guide class action lawsuit, and we can help.