Stryker Orthopedics has recalled the ShapeMatch Cutting Guide, a surgical instrument used to help implant the Stryker Triathlon Knee System. If you had a Stryker Triathlon knee replacement between May 2011 and November 2012, you may have received a poorly-fitting knee implant due to the recalled ShapeMatch Cutting Guide. Our lawyers are now accepting Stryker Triathlon knee lawsuits on behalf of individuals who suffered from joint instability, looseness, fracture, pain, limited mobility, or additional surgery.
What You Can Do & How a Stryker Triathlon Knee Lawsuit Can Help
The Schmidt Firm, LLP is currently accepting Stryker Triathlon induced injury cases in all 50 states. If you or somebody you know was injured by a Stryker Triathlon knee implant, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.
UPDATE: Class 1 Stryker ShapeMatch Cutting Guide Recall
April 18, 2013 — Stryker Orthopedics has announced a Class 1 recall for the Stryker ShapeMatch Cutting Guide, which is used to help a surgeon choose the best-fitting components of the Stryker Triathlon Knee System and mark a patient’s bone before cuts are made. The recall was issued because software defects may result in a poorly-fitting, loose knee implant and severe patient injuries. At least 44 incidents have been reported.
What is the Stryker Triathlon Knee?
The Stryker Triathlon Knee System is a brand of knee replacement that was developed by Stryker Orthopedics and approved by the FDA in 2005. Unlike older types of knee implant, which use a single hinge, the Triathlon knee pivots in a way that maintains a “single radius” design, more similar to a circle.
The Stryker Triathlon Knee Implant is fitted to a patient with the Stryker ShapeMatch Cutting Guide. This guide is used before and during surgery. The process begins when the patient undergoes an MRI (magnetic resonance image) and a computer creates a 3D image of the patient’s knee. Then, the surgeon uses the ShapeMatch Cutting Guide to choose the most appropriate components of the Triathlon knee. During surgery, the ShapeMatch also helps the surgeon mark the patient’s bones before making cuts. Accuracy is extremely important during this procedure.
Problem with the Stryker Triathlon Knee Implant
The problem with the Stryker Triathlon knee implant is that software defects in the ShapeMatch Cutting Guide may result in improper bone cuts and a poorly-fitting knee implant. In the recall notice, the FDA warned:
“FDA notified healthcare professionals of a Class 1 recall for this product due to a software defect that results in wider cutting ranges. The parameters of the manufactured cutting guides may not meet the surgeon’s pre-operative planning parameters entered via the web application. Additionally, Stryker Orthopaedics determined that another software defect resulted in the displayed parameters (e.g. depth of resection, angle of cut) not matching the cutting guides produced. This may result in serious adverse health consequences including joint instability, fracture, need for revision surgery and chronic pain and limitations of mobility.”
Stryker Triathlon Recall
The Stryker Triathlon has not been recalled. However, a surgical instrument that was used to implant the Stryker Triathlon has been recalled — the Stryker ShapeMatch Cutting Guide. This instrument was used in surgery from May 2011 until November 2012. If you had knee surgery during this time and you are now suffering from pain, looseness, limited mobility, or required revision surgery for your Stryker Triathlon knee implant, you may qualify for a lawsuit.
Stryker Triathlon Knee Injuries and Complications
There are at least 44 reports of incidents and injuries associated with the Stryker Triathlon knee implant in which the ShapeMatch Cutting Guide was used. Of these, 41 reports involved “malfunctions” and 3 involved “temporary” injuries.
Stryker Triathlon knee injuries can include:
- Misaligned knee implant
- Loose, unstable knee
- Knee dislocation
- Fracture of bone or implant
- Pain, which may be chronic or get worse
- Decreased walking ability
- Nerve damage
- Need for revision surgery
- Permanent disability or unstable knee
Do I have a Stryker Triathlon Knee Lawsuit?
The Schmidt Firm, LLP is currently accepting Stryker Triathlon induced injury cases in all 50 states. If you or somebody you know was injured by a Stryker Triathlon Knee Implant, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.
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