Couple Files OtisKnee Device Complaint in Pennsylvania Federal Court; Says Defendants Concealed Lack of FDA Approval

HARRISBURG, Pa. –– Plaintiffs in a recently filed federal lawsuit are contending that the defendants had falsely claimed that the OtisKnee device was lawfully marketed and concealed the lack of FDA approval.

In the Dec. 2 complaint filed in the U.S. District Court for the Middle District of Pennsylvania, the plaintiffs said there were known complications and unreasonable risks associated with the use of the OtisKnee device.

Plaintiffs Edra Carvell and George Carvell asserted the claims, contending that Edra Carvel, 70, underwent a right total knee replacement surgery in 2008. During the surgery, doctors implanted a Howmedica femoral component, tibial …