The Stryker ShapeMatch Cutting Guides are single-use, disposable cutting guides intended to help a surgeon mark the bone before cutting during a total knee replacement surgery. The guides ultimately assist the surgeon in the positioning of the total knee replacement components. The cutting guides are manufactured for patients individually based on imaging studies of the patients’ knee. The ShapeMatch software program uses the imaging studies to create a three-dimensional model of the patient’s knee.
The ShapeMatch Cutting Guides were manufactured and distributed from May 2011 to November 2012. Adverse event reports submitted to the U.S. Food and Drug Administration (“FDA”) have indicated that surgeons who discovered that the parameters of the cutting guide were incorrect were forced to make modifications in order to complete the knee replacement surgery. A defect in the ShapeMatch software was responsible for the incorrect cutting guide parameters.
As a result, in November 2012, Stryker emailed surgeons and imaging centers advising them to stop prescribing, planning or performing operative or imaging procedures with the ShapeMatch Cutting Guides until further notice. Subsequently, on April 10, 2013, Stryker issued an Urgent Medical Device Recall of the ShapeMatch Cutting Guides.
Due to the defect in the ShapeMatch Cutting Guides, patients may experience adverse health consequences including joint instability, fracture, the need for revision surgery and chronic pain and limitations with mobility. Stryker recommends that patients who are experiencing symptoms contact their surgeon for evaluation.
The ShapeMatch Cutting Guide was used exclusively with the Stryker Triathlon Knee System. However, the Stryker Triathlon Knee System is not subject to a recall.
The FDA has classified the Stryker ShapeMatch recall as a Class I event, the most serious type of recall since it may involve situations in which there is a reasonable probability that the use of these products will cause serious adverse health consequences or even death.
If you underwent knee surgery and the ShapeMatch Cutting Guide was used, it is important that you know and understand your legal rights. John David Hart and the Law Offices of John David Hart represent individuals in the United States who have been injured as a result of the defective Stryker ShapeMatch Cutting Guides. The Law Offices of John David Hart is a group of experienced and dedicated legal professionals working to protect the rights of people wronged by the acts of others. Across the country, the firm represents individuals in cases of catastrophic personal injury, wrongful death, dangerous drugs and medical products, automobile and truck accidents and oil and gas litigation. For more information, please contact John David Hart at 1-800-247-1623 or johnhart@hartlaw.com or visit www.hartlaw.com.
