ISSUE: FDA notified healthcare professionals of a Class 1 recall for this product due to a software defect that results in wider cutting ranges. The parameters of the manufactured cutting guides may not meet the surgeon’s pre-operative planning parameters entered via a web application.
Additionally, Stryker Orthopaedics determined that another software defect resulted in the displayed parameters (e.g. depth of resection, angle of cut) that did not match the cutting guides produced. This may result in serious adverse health consequences including joint instability, fracture, need for revision surgery, and chronic pain and limitations of mobility.
The FDA has received a total of 44 reports (41 malfunctions and 3 temporary medically reversible injuries) of incidents related to the ShapeMatch Cutting Guides.
BACKGROUND: The ShapeMatch Cutting Guides are single-use, disposable, cutting guides. They are intended to be used as surgical instrumentation to assist in the positioning of total knee replacement components, and in guiding the marking of bone before cutting.
In November 2012, Stryker Orthopaedics e-mailed field locations, registered surgeons, and imaging centers of the problem and notified them to immediately stop prescribing, planning or performing operative or imaging procedures with the ShapeMatch Cutting Guides.
In January 2013, a Product Notification was issued to all branches, agencies, surgeons, and risk managers at affected hospitals informing them of the problem and risk factors.
On April 10, 2013, Stryker issued an Urgent Medical Device Recall.
RECOMMENDATION: The ShapeMatch Cutting Guides have not been available on the market since November 2012. Stryker is recommending patients who had knee replacement surgery in which ShapeMatch Cutting Guides were used and who are experiencing symptoms to contact their surgeon immediately.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm
IF YOU HAVE BEEN INJURED:
If you or a loved one were operated on with a Stryker Orthopaedics Shape Match Cutting Guide and suffered any side effects, call Graves McLain for help at 918-359-6600. An experienced personal injury attorney will speak to you for free about your case. A personal injury lawyer will get to the facts to see if you are entitled to compensation for your injuries, pain and suffering, and loss of quality of life.
If you or a loved one have been seriously injured in an accident that was not your fault, or you feel you may have a medical malpractice related claim or need social security disability benefits, call Graves McLain, the Tulsa Personal Injury Law Firm for a free confidential consultation at 918-359-6600. An experienced attorney will review your situation at no cost to you. We represent victims and their families in serious injury and death cases arising from medical mistakes, vehicle collisions, and other accidents.
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