The Stryker’s ShapeMatch Cutting Guides was recalled in November 2012. Stryker stopped distribution of the guides and told registered surgeons and image centers to discontinue using the product.
What the ShapeMatch Cutting Guide Does
The ShapeMatch was a surgical instrument that that was used to help plan and assist replacing a knee. Basically the guide enabled surgeons to mark the bone prior to cutting it. This would then help them align the implant to your knee.
Patients would receive an MRI creating a 3D model of the patient’s knee.Using the Cutting Guide they were able to choose the device settings that best fit the patient’s joint. This was supposed to enable the surgeon to create smaller incisions with positioning that’s more accurate and a faster incision closing. Yet it obviously have not lived up to its expectations.
What Went Wrong
Essentially the software the made the cuts had a defect. It malfunctioned to create wider cutting dimensions than what the surgeon was telling it to. The display parameters did not match what was being produced by the cuts themselves. Additionally, there were guide that had been manufactured not within the guidelines of 510(k).
Side Effects People are Experiencing or Have Experienced
- Popping or clicking in knee
- Impaired mobility/motion range
- Infection around knee
- Swelling around knee
- Nerve damage around knee
- Unstable joints
- Knee dislocation
- Bone Loss
- Revision surgery
If you are experiencing any of these problems you should talk to your doctor.
What to do
You might be entitled to compensation if you have had knee replacement surgery where the Stryker‘s ShapeMatch Cutting Guide was used. There are plenty of people who are suing Stryker because of the defected problem.