A Medical Device Daily

The firm of Capretz & Associates (Newport Beach, California) reported filing a lawsuit in San Diego County Superior Court on behalf of an Escondido, California, woman who said she has suffered from continuing leg pain and other problems due to a defective surgical screw made by Smith & Nephew (S&N; London). The company's Calaxo Screw was used to repair the anterior cruciate ligament (ACL) in her left knee, damaged in a skiing accident.

The lawsuit was filed on behalf of Cheryl Dailey, 44 at the time of her accident, and her husband, Richard Dailey.

Unlike most surgical screws used in ACL repair that remain intact in the body, the Calaxo Screw was designed to dissolve and benefit the healing process, according to the lawsuit. But the suit charges that the screw not only hindered Dailey's healing, but also became disengaged from the bone in which it was implanted, becoming a source of pain, fluids and other physical problems

Several months after Dailey's first knee surgery in January 2007, S&N implemented a nationwide recall of the Calaxo Screw due to post-operative problems such as fluid build-up, potential for failure of the ACL graft, and premature material degradation.

The law firm said that an FDA recall notice estimates that nearly 68,300 Calaxo Screws have been implanted in patients. The lawsuit says that in Dailey's case, the implantation of the Calaxo Screw in her left leg resulted in significant pain to her neck, lower back, knee and shoulder and created significant fatigue.

The suit says that Dailey required two more corrective surgeries and extensive post-operative treatment and therapy. It adds that "several other similar situations have been reported across the country."

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