ConforMIS, Inc., has issued recalls for the iUni and iTotal knee replacements over safety concerns. Recently, they were hit with a lawsuit from a woman who claims the iTotal G2 knee implant is defective because components can loosen or detach — but the company failed to issue a recall.
ConforMIS iUni Knee Implant Recall
July 15, 2009 — ConforMIS has issued a Class II recall for 10 units of the iUni knee replacement because microscopic cracks could cause the implant to fail prematurely. Patients may need revision surgery.
ConforMIS iTotal Knee Implant Recall
August 17, 2012 — ConforMIS has issued a Class II recall for 1,427 units of the iTotal CR-Cruciate Retaining knee replacement to update the surgical technique guide.
Woman Injured by ConforMIS Knee Files Lawsuit in Texas
In October 2014, ConforMIS was hit with a lawsuit (PDF) in federal court in Texas from a woman who needed bilateral revision surgery after the iTotal G2 knee replacement failed in both of her knees.
She underwent revision surgery in January 2014 and endured months of recovery. Unfortunately, she had to retire due to excruciating pain in both of her knees.
What is the problem?
The iTotal G2 was originally approved with a 510(k) application, by which the FDA approves new devices without requiring safety tests so long as the device is “substantially equivalent” to another device on the market.
Just because a new device is similar doesn’t mean it is safe — between January 2011 and March 2014, lawyers point out approximately 30 reports of tibial tray loosening or spacer dislodgment on the iTotal G2.
Instead of recalling the iTotal G2, lawyers claim ConforMIS submitted another 510(k) application in April 2013, seeking approval for design changes that might fix the problem.
The problem is allegedly due to the femoral component exerting too much pressure on the back of the tibial spacer. When the parts grind together, the spacer can dislodge or the tray can loosen. These complications must be treated with revision surgery.