The U.S. Food & Drug Administration (FDA) has notified healthcare professionals of a nationwide recall for Stryker Corp’s ShapeMatch Cutting Guide. These devices are used as surgical instrumentation in total knee replacement operations, but have recently been linked to inaccurate cutting ranges which may not meet the surgeon’s pre-operative planning parameters. When this occurs, serious health complications can result in knee replacement recipients including joint instability, fracture, the need for revision surgery, chronic pain and limitations of mobility.
Free Confidential Lawsuit Evaluation: If you or a loved one suffered serious complications after undergoing total knee replacement with a Stryker ShapeMatch Cutting Guides System included in this recall, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against Stryker Corp. and we can help.
Stryker ShapeMatch Cutting Guide Overview
The Stryker ShapeMatch Cutting Guide is designed to be used with the company’s Triathlon Knee System, and works by helping surgeons mark the area of bone to be cut during knee replacement procedures. The devices are custom made according to 3-D images of the patient’s knee, which are provided by MRI or CT scans. The ShapeMatch Cutting Guides System hit the U.S. market in May 2011 after being cleared through the FDA’s controversial 510(k) premarket approval loophole, which approves devices that are ‘substantially equivalent’ to products already on the market.
Why was the ShapeMatch recall issued?
According to a press release issued by the FDA on April 10, 2013, Stryker Corp. issued the ShapeMatch recall due to a software defect that caused wider cutting ranges which may not meet the surgeon’s pre-operative planning parameters entered through the web application. Additionally, the company determined that another software defect caused the displayed parameters (e.g. depth of resection, angle of cut) to be inconsistent with the cutting guides produced. These defects have the potential to cause serious health complications in knee replacement recipients including (but not limited to):
- joint instability
- need for revision surgery
- chronic pain
- limitations of mobility
To date, the FDA has received reports of at least 41 malfunctions and 3 injuries associated with Stryker ShapeMatch Cutting Guides. In November 2012, the company e-mailed field locations, registered surgeons, and imaging centers advising them to stop performing surgeries with the devices until further notice. Then in January 2013, a Product Notification was issued to all branches, agencies, surgeons, and risk managers at affected facilities informing them of the problem and risk mitigation factors. The ShapeMatch Cutting Guide was officially recalled nationwide on April 10, 2013. Stryker Corp. has advised knee replacement patients to contact their surgeons if they are experiencing complications. If symptom-free, the patient should continue to follow-up with the surgeon at regular intervals.
Do I Have a Stryker ShapeMatch Lawsuit?
The 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 Lawsuits. We are handling individual litigation nationwide and currently accepting new ShapeMatch Cutting Guide injury cases in all 50 states.
Free Confidential Lawsuit Evaluation: If you or a loved one had complications following total knee replacement with a Stryker ShapeMatch Cutting Guides System, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.