What is the Stryker Triathlon Knee Implant?
The Stryker Triathlon Knee Implant is a medical device used in total knee replacement surgery (arthroplasty). It is manufactured by Stryker Orthopedics and was approved by the FDA in 2005. Unlike traditional knee implants, which use a single hinge, the Stryker Triathlon uses a “single radius” design, which means that the radius does not change as the knee flexes — similar to a circle.
The Stryker Triathlon is implanted using the Stryker ShapeMatch Cutting Guide. Before surgery, a patient undergoes an MRI (magnetic resonance imaging) test, and a computer makes a 3D image of the patient’s knee. The ShapeMatch cutting guide helps the surgeon select components of the Triathlon Knee System that will best match the patient’s unique anatomy. The ShapeMatch also helps a surgeon mark the patient’s bone before making cuts.
Problem with the Stryker Triathlon Knee Implant
Many people have suffered problems with their Stryker Triathlon knee implant because of defects with the ShapeMatch Cutting Guide. Unfortunately, software problems can cause serious problems. According to the FDA:
“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 Knee System has not been recalled. However, the ShapeMatch Cutting Guides that were used to implant the Triathlon have been recalled. Stryker issued a Class 1 recall, which is the most serious type of recall. The recalled ShapeMatch Cutting Guides were used in knee replacement surgeries between May 2011 and November 2012. Patients who had knee surgery during this time and who are now having problems with their Triathlon knee replacement may qualify for a knee implant lawsuit.
Stryker Triathlon Knee Injuries and Complications
Stryker has received 44 reports of incidents involving the Triathlon knee implant and the ShapeMatch cutting guides. Of these, 41 were described as “malfunctions” and 3 were described as “medically reversible” injuries.
Stryker Triathlon knee injuries can include:
- Knee misalignment
- Loose or unstable knee implant
- Dislocated knee
- Bone fractures or fractured implant
- Limping, abnormal gait, or limited mobility
- Stiffness or decreased flexibility
- Nerve damage
- Need for additional surgery (revision surgery)