Class 1 FDA Recall of Stryker Orthopaedics ShapeMatch Cutting Guide
On April 10, 2013, the FDA issued a Class 1 recall – the most urgent recall the FDA will issue – of the Stryker Orthopaedics ShapeMatch Cutting Guide. The recall occurred because a computer software defect was causing wider cutting ranges.
The Stryker ShapeMatch Cutting Guide is a system used during the pre-operation stage of a total knee replacement (arthroplasty). The patient undergoes an MRI that creates a 3D image of the knee. The Stryker ShapeMatch Cutting Guide, used with the Triathlon Knee System, then would assist the surgeon in choosing the correct size, position and alignment of the “new knee.” The manufacturer claimed that using this technique would provide a better outcome.
The Stryker ShapeMatch Cutting Guide was manufactured and distributed from May 2011 to November 2012 in the United States.
The FDA has received multiple reports of incidents due to the ShapeMatch Cutting Guide. Serious injuries from this product, which could include death, are:
- Revision surgery
- Chronic pain
- Knee fracture
- Permanent limitations of mobility
- Nerve damage
- Abnormal sounds in the knee (clicking, popping, grinding, etc.)
Stryker Orthopaedics Matching Guides have been under scrutiny for some time. According to Stryker Orthopaedics, the ultimate reason for the FDA recall was, “The parameters of the manufactured cutting guides may not meet the surgeon’s pre-operative planning parameters entered via the web application. Additionally, the company determined that another software defect resulted in the displayed parameters (e.g., depth of resection, the angle of cut) not matching the cutting guides produced. The result is serious adverse health consequences including joint instability, fracture, need for revision surgery and chronic pain and limitations of mobility.”
In November 2012, Stryker Orthopaedics emailed field locations to stop immediately prescribing or planning operative or imaging procedures with the ShapeMatch Cutting Guides until further notice.
In January 2013, a product notification was sent out to all agencies, surgeons and hospitals informing them of the problem and risk factors.
Eight days before the FDA recall in April 2013, Stryker Orthopaedics announced an Urgent Medical Device Recall. This recall recommends patients who had knee replacement surgery and who are experiencing symptoms to contact their surgeon. Patients may also contact Stryker at 1-888-STRYKER with questions regarding this Class I recall Monday – Friday, 8am-8pm EST.
What To Do
We are conveniently located in several locations in the states of New York and Vermont to ensure you have an attorney close to you: Schenectady, NY, Albany, NY, Saratoga, NY, Plattsburgh, NY, Buffalo, NY, New York City, NY, White Plains, NY, Rochester, NY – as well as Manchester, VT and Burlington, VT. If you or someone you know has suffered any lasting medical complications from the Stryker ShapeMatch Cutting Guide, call your local office toll free at 1800LAW1010 (1.800.529.1010) to speak a representative today.
Harding Mazzotti, LLP is currently reviewing claims that resulted in serious injury from the use of the Stryker ShapeMatch Cutting Guide. Call the Heavy Hitters to investigate your claim. Call us at 1-800-LAW-1010 or fill out a contact form.