Pa. Woman Says Defective, Unapproved OtisKnee Measuring/Cutting Device Caused Knee Prosthesis to Fail

HARRISBURG, Pa. — A woman who was required to undergo revision surgery due to loosening of her total knee replacement device has sued the makers of the OtisKnee measuring and cutting device, alleging that the device was defectively designed and manufactured and was not cleared by the Food and Drug Administration.

In a Dec. 2 complaint filed in the U.S. District Court for the Middle District of Pennsylvania, the plaintiff alleges that had she or her physician known that the OtisKnee device had not been approved by the FDA at the time of surgery, it would not have been used …