ConforMIS, Inc., has been hit with a lawsuit in Texas alleging that the iTotal G2 knee replacement is defective. At least 30 incidents report that the tibial tray or plastic spacers can loosen and dislocate prematurely. This complication can cause excruciating pain and require revision surgery.
Overview
The iTotal G2 is a knee replacement created by ConforMIS, Inc., based in Massachusetts. It uses 3D technology and CT scans to create a custom-fitted implant for each patient. Components of the iTotal G2 include:
- Femoral implant: Fixed onto the base of the femur.
- Tibial tray: Fixed onto the head of the tibia.
- Spacers: Made of plastic (polypropylene) and sandwiched between the femoral and tibial implants, the spacers are supposed to remain fixed on top of the tibial tray. Lawsuits allege that the spacers and/or tibial tray can loosen.
510(k) Approval
The FDA approved the ConforMIS iTotal G2 in January 2011 without requiring clinical trials to prove safety or effectiveness. It was approved under the 510(k) loophole, which allows manufacturers to sell new devices without conducting new studies, so long as the device is “substantially equivalent” to a device already on the market.
Texas Woman Files 1st ConforMIS Knee Replacement Lawsuit
October 21, 2014 — Texas attorneys have filed a lawsuit (PDF) against ConforMIS, Inc., on behalf of a woman who was injured by two defective iTotal G2 knee replacements.
The lawsuit was filed in the U.S. District Court for the Southern District of Texas. The plaintiff, 65 year-old Mary Jane Martine, was implanted with two iTotal G2 knee replacements in October 2012 and April 2013.
Both of the implants failed in December 2013, causing excruciating pain and disability. Martine, a former nurse, was forced to retire early because she could not walk.
In January 2014, Martine underwent revision surgery. Surgeons discovered that the plastic spacer in her right knee had moved out of place, turned, and twisted up into her femur. On her left knee, the tibial tray was loose and caused bone damage.
What is the problem?
As of March 2014, the FDA has received about 30 reports of spacer dislodgment or tibial tray loosening. In April 2013, ConforMIS submitted another 510(k) application seeking approval for design changes, allegedly aimed at fixing the problem.
According to a lawsuit:
“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 is accused of negligence for selling a knee replacement they knew was defective, failing to issue an appropriate recall, and failing to adequately warn surgeons about safety risks.
Complications
- 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
ConforMIS Knee Recall
August 17, 2012 — ConforMIS has issued a Class II recall for about 1,427 of the iTotal CR-Cruciate knee replacement to update the surgical technique guide.
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