In the last few years, ConforMIS, Inc. has recalled the iTotal and iUni knee replacements to address safety problems with a low risk of causing injury. Now, they are facing a lawsuit from a woman who claims the iTotal G2 is defective because components loosened prematurely, forcing her to undergo revision surgery in both of her knees.
ConforMIs Recalls iUni Knee Replacement
In July 2009, ConforMIS recalled 10 of the iUni (Unicondylar Knee System) due to concern about microscopic cracks that could potentially increase a patient’s risk of premature revision surgery. The Class II recall did not cite any patient injuries.
ConforMIS Recalls iTotal Knee Replacement
ConforMIS recalled 1,427 units of the iTotal CR (Cruciate Retaining) knee replacement and added prominent updates to the surgical technique guide. The Class II recall was issued in August 2012.
ConforMIS iTotal G2 Lawsuit
October 2014 — Lawyers have filed a lawsuit accusing ConforMIS of selling a defective iTotal G2 knee replacement that broke after approximately one year, forcing a woman to undergo revision surgery in both of her knees.
The lawsuit was filed in Texas federal court. The plaintiff, a 65 year-old woman, was implanted with the devices in October 2012 and April 2013. In December, she heard a “popping” noise in her right knee and was unable to walk due to excruciating pain.
What’s the problem?
Doctors discovered that the plastic spacer in her right knee had dislodged and rotated upward into her femur. The tibial tray in her left knee was also loose and caused bone damage.
Lawyers warn that the iTotal G2 was approved with a 510(k) application, which does not require new safety studies so long as it is “substantially equivalent” to another device on the market.
They claim that the femoral component of the iTotal G2 puts too much pressure on the spacers, which can cause them to dislodge and loosen the tibial tray. Instead of recalling the knee implant, in April 2013, ConforMIS submitted another 510(k) application, allegedly to fix problems with the iTotal G2.
she was forced to undergo bilateral revision surgery in both of her knees in January 2014. Due to the pain and prolonged rehabilitation, she was also forced to retire early. She is seeking compensation for her pain and suffering, lost income, medical expenses, and more.