A Medical Device Daily

A West Virginia couple has filed a lawsuit in U.S. District Court, Middle District of Pennsylvania, against a State College, Pennsylvania, orthopedic surgeon and Encore Medical (Austin, Texas), charging that they manufactured a defective knee replacement device that the doctor implanted in both knees of the 63-year-old woman. And the attorney representing them says that the company’s knee replacements “are ticking time bombs.”

The lawsuit, filed on behalf of Camilla and Michael Hendrix, alleges that both the implanting surgeon, Kenneth Cherry, MD, and Encore knew that the device — called a polyethylene tibial insert — was defective and had the potential of breaking, and producing a variety of adverse effects. Cherry, an owner of University Orthopedics & Sport Medicine (College Park, Maryland), also is named as a defendant.

The complaint alleges that Encore violated Pennsylvania’s unfair trade practices and consumer protection laws and accuses Cherry of medical battery, alleging that, “As the treating orthopedic physician ... Cherry was required to provide [her] with all material information necessary ... to determine whether to proceed with the implantation of the Encore orthopedic knee devices ... “ It says that Cherry knew that the implant was dangerous and defective.”

Cherry replaced both of Mrs. Hendrix’s knees with the Encore devices in May 1999. In 2003, the complaint says she began suffering from the “feeling of instability” in her right knee and that the Encore device was surgically replaced in November, during which it was discovered that the device’s tibial post that anchors it to the recipient’s bone, had broken. It says that the claim for that injury was “satisfactory resolved” but that she will need additional surgery to remove the scarring.

According to the new complaint, she began having swelling and “excruciating pain” in her left knee and began to hear a “clunking” sound in the knee. It says that Cherry found that the post of the Encore insert in that knee also fractured, requiring replacement surgery and months of rehabilitation.

Attorney James Capretz of Capretz & Associates (Newport Beach, California) alleges that both Encore and Cherry knew or should have known as early as 1995 that the tibial insert was faulty when problems with it began surfacing with the FDA but that they continued to use the implant in patients. He says that Mrs. Hendrix was never informed of any problems with the device.

The complaint further states that prior to May 1999 when Dr. Cherry implanted the Encore devices in Mrs. Hendrix, he “had performed multiple revision procedures to correct problems which developed with Encore prosthetic knee devices previously implanted on several patients for whom he and other physicians at University Orthopedics were the primary implanting physicians and upon whom defective Encore orthopedic knee devices were implanted ... .”

“Because neither Encore nor the attending physicians tried to inform people who had the knee device of the inherent problems with the product, we believe it’s possible that there could be many other Encore knee replacement patients in Pennsylvania and surrounding states that could have the faulty device in them and they don’t even know it,” Capretz said.

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