Knee joint replacement device manufacturer Smith & Nephew has announced a recall of the cementless versions of its Oxinium Genesis II and Oxinium Profix II knee joint replacement systems. Smith & Nephew previously had stopped sales of the products and alerted the United States Food and Drug Administration of the problems associated with the knee joint replacements.

The problem with the cementless Oxinium Genesis II and Oxinium Profix II knee joint replacement systems resulted in knee replacement joint replacements failing to bond properly with patients' bones. Smith and Nephew has reported that 3,000 patients were fitted with the products in the United States. Patients with the defective implants are at an increased risk for further complications. In addition to the revision surgery; complications include infection, bone loss, scarring, and muscular damage.

Oxinium, or oxidized zirconium, is a relatively new material being used by the company which was intended to produce longer-lasting replacement joints. Oxidized zirconium is a metallic alloy-based material used in hip and knee products in order to improve their longevity. Smith and Nephew's product literature claims that "Oxidized Zirconium combines the best of both ceramic and metal. It is a metal, with excellent fracture toughness like cobalt chrome, but is has a ceramic surface that offers outstanding wear resistance."

The cementless versions of the Oxinium Profix II Knee Systems were macrotextured to facilitate bonding with a patient's bones. In a June 18, 2002 press release, Smith & Nephew stated:

The Profix Oxinium macrotextured femoral component features a roughened, three-dimensional contour to the fixation surface of the implant. A proprietary chemical photo-etching process creates a highly controlled and reproducible surface that has been engineered for optimum fixation. This surface, with a mean pore size of 350 microns, is not a coating but an integral part of the base metal.

It appears as if this macrotexturing failed to allow proper bone bonding resulting in the implant loosening from the bone.

The London based Smith & Nephew has its United States headquarters in Memphis, Tennessee.

If you believe that your Smith and Nephew Oxinium knee prosthesis failed because it was defective, the trial lawyers of the Maglio Christopher & Toale Law Firm will be glad to review your medical records to determine whether we feel there are sufficient grounds for us to represent you in pursuing a lawsuit against the manufacturer. Click here for our online potential case evaluation form.

Typically in order to review a case, we need the orthopedic surgeon's office chart, the operative reports for the original joint replacement surgery and the revision surgery, and the device record for the original surgery from the hospital chart (this shows the product and lot numbers of the components of the device). We also like to have the device. Therefore, it is essential that you get possession of the device as soon as it is removed. It may still be possible to do the case with no device, but it will be much more difficult.