Numerous issues with different brands of knee implants and devices have been reported in the past decade. Because of these defective or dangerous products, patients who go in for a knee surgery with hopes of regaining a normal, active life sometimes end up instead with more pain and less mobility. One of the most recent reports of potentially dangerous knee-replacement devices involves the Stryker Triathlon Total Knee System. The device comes with the Stryker ShapeMatch Cutting Guide, which is a piece of software that helps surgeons choose how to place the implant during the procedure based on the patient’s anatomy. The ShapeMatch Cutting Guide software for the knee-replacement system has been recalled, and some patients who experienced problems with their implants are now taking steps to hold the company responsible for the costs of their injuries.
What Problems Are Associated With Stryker Triathlon Knee Implants?
The problems patients have experienced may be due to a defective software application that was issued with Stryker Triathlon Total Knee Systems. The Stryker ShapeMatch Cutting Guide software is used with the implants to create patient-specific plans for placement of the device and making surgical cuts. Two defects in the software led to a recall from the U.S. Food and Drug Administration (FDA) because:
- The plans produced by the software may not have accurately represented the values entered by the surgeon, meaning that cutting ranges could be too wide.
- A defect in the software could produce cutting guides that did not meet the other patient-specific parameters entered into the system by surgeons.
Patients who were affected by knee replacements that used the potentially defective software have reported a number of serious issues postoperatively, including:
- Chronic or worsening pain
- Poor positioning of the implanted knee device
- Failure of surgery
- Need for additional surgeries
- Loss of mobility, whether temporary or permanent
- Nerve damage
- Bone fractures
Have Stryker Triathlon Knee Implants Been Recalled for These Issues?
The Stryker Triathlon Total Knee System has not been recalled, but the Stryker ShapeMatch Cutting Guide software used in the implantation of the device has been. Stryker stopped sales of the software in November 2012, and the FDA followed with a recall for Stryker ShapeMatch Cutting Guides in April 2013. The defective software may have been an issue for patients who had knee surgeries between May 2011 and November 2012. So far, the FDA has received complaints from 44 people who have had issues related their Stryker Triathlon knee replacements.
Do I Have a Lawsuit for Problems Related to the Stryker Triathlon Total Knee System?
Families harmed by dangerous medical devices do have the right to pursue compensation and hold manufacturers responsible for the physical, financial, and emotional impact of a defect. However, holding huge medical-device manufacturers responsible for defective devices is challenging, and many complicated factors can impact an individual’s eligibility and chances for success.
If you had knee surgery between May 2011 and November 2012 and are concerned about the Stryker recall, you can get fast, free answers about your rights and options for recovery today. Our attorneys are currently reviewing cases for potential lawsuits from victims of the defective software, and we offer a free initial meeting to talk directly with clients about their concerns. Start learning more today! Simply call our friendly office at 1-(877) 724-7800, or use the live-chat service on this page to connect with someone now.