What is the ConforMIS iTotal G2?
ConforMIS Inc., a Massachusetts-based medical device company, manufactures the iTotal G2 custom knee replacement. It was approved by the FDA in January 2011. The iTotal system incorporates 3D technology to generate a custom-fit knee implant based on CT scans of the patient’s knee.
Components of the iTotal G2 include a femoral implant, fitted at the base of the femur, and a tibia tray, fitted at the head of the tibia. Between these components are two polypropylene (plastic) spacers. The spacers are supposed to lock onto the tibial tray, but recent lawsuits claim they can dislodge or loosen.
The ConforMIS iTotal G2 was approved through the FDA’s 510(k) approval process, which does not require clinical testing to prove that the device is safe and effective — manufacturers must only show that the device is “substantially equivalent” to a device already on the market.
What is the problem?
Lawsuits allege that the FDA received about 30 reports of spacer dislodgment or tibia tray loosening between the launch of the iTotal G2 and March 1, 2014.
According to the complaint, ConforMIS submitted another 510(k) application to the FDA in April 2013, asking permission to modify the iTotal G2 to fix the problem:
“These changes to the iTotal were necessary because when the knee was flexed, the femoral component exerts an inordinate amount of pressure on the posterior side of the lateral tibia spacer. This led to a grinding of the spacer, and in some cases spacer dislodgment and/or tibia tray loosening.”
ConforMIS allegedly knew that the original design was defective, but they did not issue a recall or tell surgeons about the problem. When Mary Jane Martine had a defective knee implanted in April 2013, her surgeon was not aware of the risk.
ConforMIS is accused of failing to provide warnings about the following risks, which they knew could potentially injure patients:
- High rate of failure of the iTotal G2
- Tibia spacer dislodgment
- Tibia tray loosening
- Chronic pain
- Surgery to remove the iTotal G2
- Painful and prolonged recovery
Class II Recall Issued for ConforMIS iTotal Knee Replacement
In July 2012, ConforMIS issued an urgent warning to surgeons about the iTotal CR-Cruciate knee replacement and updated the surgical technique guide. In August, the FDA ordered a Class II recall for nearly 1,500 of the implants.