A recent lawsuit filed against ConforMIS, Inc., claims that the FDA has received about 30 reports of problems with the iTotal G2, a knee replacement that can loosen and fail prematurely.
In October 2014, ConforMIS, Inc. was hit with a lawsuit (PDF) in federal court in Texas. The plaintiff needed surgery to remove two defective iTotal G2 implants in both of her knees. She had one implant for only four months; the other for about one year.
Lawyers accuse ConforMIS of negligence for failing to adequately test or design that iTotal G2. They claim the femoral implant puts too much pressure on the tibial tray, which increases the risk of spacer dislodgment and loosening. According to the lawsuit, ConforMIS knew about the problem and tried to fix it in 2013 — instead of issuing a recall or warning surgeons about the problem.
What is the problem?
- Premature failure of the knee replacement
- Chronic pain
- Bone loss
- Loosening or dislocation of the spacer or tibial tray
- Limited mobility
- Revision surgery
- And more