Stryker ShapeMatch Lawsuit in 2024 (Latest Updates)

Complimentary Private Evaluation for Stryker Triathlon Knee Replacement Legal Action: Should you or someone close to you have experienced severe complications following total knee replacement or revision surgery involving the use of a Stryker ShapeMatch Cutting Guides System, currently subject to a Stryker Knee Recall, it’s important to get in touch with our legal team without delay. You could qualify for financial restitution by initiating a lawsuit for Stryker Knee Replacement, and our attorneys are here to assist.

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.

Why was the Stryker ShapeMatch Cutting Guide Recall Issued?

According to a press release 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 that may not meet the surgeon’s pre-operative planning parameters entered through the web application [1].

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.

The Stryker Technology differs fundamentally from other templating concepts with respect to the alignment philosophy of the implant and the soft tissue management, said Tilman Calliess, MD, Teamleader Orthopedic Oncology, Hannover Medical School.

Data from 24 patients and 6 surgeons were analyzed. Intraclass correlation coefficients for all measurement parameters were in the range of 0.889-0.997 (excellent), and all comparisons were statistically significant (p < 0.001).

As claimed by the National Library of Medicine, the range for femoral varus/valgus was 0.0-1.5°, with 96% of patients being within 0.5°. For femoral flexion/extension, the range was 0.0-3.5° (92% within 2.5°). On the tibia, varus/valgus had a range of 0.0-1.0° (92% within 0.5°), and for slope, the range was 0.0-3.5° (92% within 2.5°). The high degree of agreement indicated that intra-surgeon variation was minimal and that the technique was reliable stated in this 2013 research by the National Library of Medicine [2].

FAQs

Who can file a lawsuit related to the Stryker ShapeMatch Cutting Guides?

Individuals who have experienced complications or required revision surgery due to defective Stryker ShapeMatch Cutting Guides can file a lawsuit. Consulting with a personal injury lawyer specializing in medical device litigation can help determine eligibility and guide the legal process.

How long do I have to file a Stryker ShapeMatch recall lawsuit?

The time limit to file a Stryker ShapeMatch recall lawsuit, known as the statute of limitations, varies by state. It’s crucial to consult with a lawyer promptly to ensure your claim is filed within the legal timeframe to preserve your rights.

What evidence is needed to support a Stryker ShapeMatch recall lawsuit?

Evidence needed to support a Stryker ShapeMatch recall lawsuit includes medical records showing the use of the cutting guides and resulting complications, expert testimony linking the device to the injuries, and any documentation of additional surgeries or treatments required.

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See all related medical device lawsuits our attorneys covered so far.

Get a Free Stryker ShapeMatch Cutting Guide Lawsuit Evaluation With Our Lawyers

The Medical Device Litigation Group at Schmidt & Clark, LLP 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.

References:

1. https://www.fda.gov/Safety/Recalls/ucm347552.htm
2. https://misuse.ncbi.nlm.nih.gov/error/abuse.shtml