Stryker Orthopedics recalled the ShapeMatch Cutting Guide due to the risk of inaccurate bone cuts. Patients may receive a poorly-fitting Triathlon Knee Replacement or suffer joint instability, looseness, fracture, pain, disability, or require revision surgery.
UPDATE: Stryker Triathlon Lawsuit
In October 2014, a man who had an allergic reaction to cobalt and nickel in the Stryker Triathlon knee replacement has filed a lawsuit (PDF) in Colorado. Click here to read more.
Stryker Recalls ShapeMatch Cutting Guide
In April 2013, Stryker recalled the Stryker ShapeMatch Cutting Guide, which is used to help a surgeon make bone cuts before implanting a Triathlon Knee System. The recall was issued because software defects may result in inaccurate bone cuts, a poorly-fitting implant, loose or unstable knees, severe pain, and other injuries that require revision surgery. At least 44 incidents were reported to the FDA.
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.
What is the ShapeMatch Cutting Guide?
The Stryker Triathlon Knee Implant is fitted to a patient with the 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 ShapeMatch Cutting Guide was sold from May 2011 until November 2012. If you had knee surgery and you are now suffering from pain, looseness, limited mobility, or required revision surgery for your knee implant, you may qualify for a lawsuit.
How Many Incidents Were Reported?
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.
Knee Injuries & Complications
- Misaligned knee implant
- Loose, unstable knee
- Knee dislocation
- Fracture of bone or implant
- Pain, which may be chronic or get worse
- Limping
- Decreased walking ability
- Stiffness
- Nerve damage
- Infection
- Need for revision surgery
- Permanent disability or unstable knee
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