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Stryker ShapeMatch Lawsuit | Get the Right Lawyer

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 surgery, 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.
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Free Confidential Stryker Triathlon Knee Replacements Lawsuit Evaluation: If you or a loved one suffered serious complications after undergoing total knee replacement surgery or revision surgery with a Stryker ShapeMatch Cutting Guides System included in this Stryker Knee Recall, you should contact our law firm immediately. You may be entitled to compensation by filing a Stryker Knee Replacement Lawsuit and our lawyers can help.

Stryker ShapeMatch Cutting Guide Overview

The Stryker ShapeMatch Cutting Guide is designed to be used with the Stryker Triathlon Knee Replacement System, and works by helping surgeons mark the area of bone to be cut during knee replacement surgery or revision surgery.

The Stryker ShapeMatch Cutting Guide is custom made according to 3-D images of the patient’s knee implant, which are provided by MRI or CT scans. The Stryker ShapeMatch Cutting Guide 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 knee replacement surgery products already on the market.

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Why was the Stryker ShapeMatch Cutting Guide Recall Issued?

According to a press release [1] issued by the FDA on April 10, 2013, Stryker Orthopaedics issued the Stryker 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, Stryker Orthopaedics determined that another software defect caused the displayed parameters (e.g. depth of resection, angle of cut) to be inconsistent with the Stryker ShapeMatch Cutting Guide produced. These defects have the potential to cause the following serious health complications in patients who have undergone knee replacement surgery:

  • joint instability
  • fracture
  • need for revision surgery
  • chronic pain
  • limitations of mobility
  • other Stryker knee implant problems

To date, the FDA has received reports of at least 41 malfunctions and 3 injuries associated with the Stryker ShapeMatch Cutting Guide. In November 2012, the company e-mailed field locations, registered surgeons, and imaging centers advising them to stop performing surgeries with the Stryker ShapeMatch Cutting Guide 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 with the Stryker ShapeMatch Cutting Guide and risk mitigation factors.

The Stryker 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.

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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 Cutting Guide Lawsuits. We are handling individual litigation nationwide and currently accepting new Stryker ShapeMatch Cutting Guide injury cases in all 50 states.

Free Confidential ShapeMatch Cutting Guide Lawsuit Evaluation: If you or a loved one had complications following total knee replacement with a Stryker ShapeMatch Cutting Guide System, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.

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