ConforMIS, Inc., is facing a lawsuit alleging that the iTotal G2 knee implant is defective because components can loosen and fail prematurely. This lawsuit cites 30 complaints about the problem between 2011-2014.
Overview
A lawsuit involving the ConforMIS iTotal G2 knee replacement has been filed in Texas federal court, but it is not part of a class action — it is an individual lawsuit filed by a woman who contacted an attorney.
Her problems began in December 2013, when she heard a “popping” noise and suffered excruciating pain in her right knee. Her doctor found that the plastic spacer in one knee had come loose and rotated upward into her femur. In the other knee, the tibial tray was loose and caused bone damage.
According to the complaint, ConforMIS failed to adequately test or design the iTotal G2. Lawyers claim that soon after it was approved, the FDA received about 30 complaints of spacer detachment or loosening — but instead of issuing a recall, ConforMIS tried to fix the problem in 2013. Meanwhile, the iTotal G2 was marketed as safe and effective.
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
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