GRAVES MCLAIN ATTORNEYS INVESTIGATE STRYKER SHAPEMATCH CUTTING GUIDE CLAIMS
The attorneys at Graves McLain are currently investigating claims involving the Stryker ShapeMatch cutting guide. The ShapeMatch Cutting Guide was used during knee replacement surgery in conjunction with the Stryker Triathlon Knee implant. The ShapeMatch Cutting Guide is a single-use, disposable cutting guide. They are to be used for marking bone cutting prior to surgery and as surgical instrumentation to assist in the positioning of the knee replacement components during surgery. The ShapeMatch Cutting Guide was approved through the FDA’s 501K process in May 2011. In November 2012 Stryker ceased marketing the cutting guide and instructed surgeons to stop using the product. In April 2013 the FDA issued a Class I medical device recall for the ShapeMatch Cutting Guide.
Concerns for this device are that the cutting guide does not meet FDA parameters and does not meet the parameters entered into the program by the doctor. These deficiencies result in misalignment, joint instability, fracture, limited mobility, chronic pain many times leading to the need for revision surgery.
Potential damages and problems arising from the ShapeMatch cutting guide deficiencies:
• Component misalignment
• Abnormal sounds (scraping, popping, clicking)
• Decreased mobility and range of motion
• Limping or difficulty walking
• Chronic pain (which may worsen over time)
• Nerve damage
• Bone Loss
• Joint instability
• Premature loosening of the joint
• Revision surgery
If you or a loved one had a total knee replacement surgery with the Stryker Triathlon knee and you have suffered complications, pain, instability, bone loss or other problems call our office for a free consultation.