Texas Injury Lawyer for Bad Knee ImplantsDecember 7, 2016 — A lawsuit has been filed by a woman who needed revision surgery for a bad knee replacement she blames on the OtisKnee Cutting Guide, which was on the market illegally.

The lawsuit (PDF) was filed by Edra Carvell, a 70 year-old woman from Pennsylvania who had her right knee replaced in 2008.

Her surgeon used the OtisKnee Cutting Guide to make measurements and cut bones in her leg to properly fit knee implants made by Stryker.

Soon afterward, she developed progressively worsening pain. The knee implant loosened and she was unable to walk without a cane. Less than a year after her surgery, she required revision surgery.

Lawyers say her surgeon never would have used the OtisKnee Cutting Guide if he had known it was not approved by the FDA.

According to the New York Times, OtisMed sold 18,000 unapproved cutting guides from May 2006 through November 2009.

In 2008, OtisMed finally asked the FDA to approve the guide. In 2009, just as Stryker was preparing to buy the company for $100 million, the FDA denied the application due to a lack of safety information.

The board of OtisMed voted unanimously to stop shipments, but C.E.O. Charlie Chi ordered employees to ship a batch of 218 cutting guides to surgeons after the FDA expressly warned the company against selling the devices. The Justice Department imposed over $80 million in criminal and civil fines. Chi was sentenced to two years in prison and $75,000 in fines.

The lawsuit was filed on December 2, 2106 in the U.S. District Court for the Middle District of Pennsylvania — Edra Carvell, et al. v. Stryker Corporation, et alCase No. 1:16-cv-02410.

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