ConforMIS Sued in Texas Over Allegedly Defective Custom Knee Implants

HOUSTON — A Texas woman has sued ConforMIS Inc., alleging that its iTotal G2 custom knee implant is defectively designed, resulting in spacer dislodgments and tibia tray loosening.

In an Oct. 21 complaint filed in the U.S. District Court for the Southern District of Texas, the plaintiff accuses ConforMIS of failing to inform doctors and the public of these defects and resulting adverse events. This is the first such lawsuit filed against ConforMIS, according to the plaintiff’s counsel.

The iTotal system, which received 510(k) approval in 2011, generates patient-specific knee implants using CT scans to build a 3D image of …