Monday, November 12, 2012

Stryker Hip Implants

Waters, Krause, Paul

Waters, Kraus & Paul fight for those injured by unsafe Stryker hip Implants.

Hundreds, if not thousands, of Americans are now suffering after receiving unsafe hip implants made by Stryker Orthopaedics. But it wasn’t supposed to be this way. When Stryker introduced its new Rejuvenate and ABGII hip implant systems to the market in late 2009 and early 2010, the company touted the devices as revolutionary and free from the problems that had caused many of its competitors’ hip replacements to be recalled. Traditional hip devices use a one-piece neck and stem. With the Stryker Rejuvenate system, the surgeon could choose between six interchangeable stems and sixteen necks. The ABGII system had even more options – sixteen stems and ten modular necks. This flexibility was supposed to allow the hip implant to be custom-fitted to an individual patient.

Stryker marketed its hip systems for use in younger patients because the devices were said to last longer than conventional hip replacements. Further, Stryker claimed that the Rejuvenate and ABG II modular hip implants were made with ceramic bearing surfaces, so the implants posed no risks caused by the metal-on-metal surfaces of Stryker’s competitors’ faulty devices.

The truth about Stryker’s Rejuvenate and ABGII hip replacement systems.

Unfortunately, Stryker’s claims turned out to be untrue. The Rejuvenate and ABGII hip systems were, if anything, even more dangerous than the hip implants that other companies had already recalled from the market.

Both hip systems were approved under the U.S. Food and Drug Administration’s controversial 510(k) process, which approves medical devices without requiring clinical trials if the device maker shows that the product is essentially similar to one the FDA has already approved. Unfortunately, the dangers in the Stryker hip systems were not revealed until they had already been implanted in thousands of patients.

Indeed, the Stryker hip systems have the same risks for metal toxicity and metallosis that the other metal-on-metal hip systems have. While Stryker’s hip systems do not have a metal-on-metal bearing surface, they do have a metal-on-metal surface at the taper neck junction where the interchangeable neck fits into the stem. At that point, two dissimilar metals come into contact with each other, causing the same corrosion, creation of metal debris, galvanization, and fretting that exists with the DePuy ASR and Pinnacle and Biomet systems as well as other dangerous metal-on-metal hip implants.

Patients’ adverse reactions to the Stryker Rejuvenate and ABGII hip implants were so troubling that in July 2012, Stryker finally issued a recall of the systems after the FDA reported patient complaints about issues such as:

  • Heavy metal poisoning
  • Bone fractures
  • Extreme pain and swelling
  • False tumors and fluid collection around implant

Revision surgery for Stryker hip implants the most painful of all.

The solution for injuries caused by defective metal-on-metal hip implants is, unfortunately, revision surgery. The surgeon re-operates and replaces the defective part. Unlike other defective hip products, the necessary revision surgery is even more traumatic, requiring the femoral stem to be removed with the Stryker Rejuvenate and ABG II hip implants. The stem is driven deep into the femur. Once bone grows through the special coating into the stem, the new bone growth is a permanent part of a patient’s body. The revision surgery needed to remove the femoral stem often requires the surgeon to cut lengthwise down the femur to free the stem. After the old defective stem is removed, it must be replaced with a new “revision” stem that is often longer and larger. Revision surgery for Stryker hip systems is quite complicated, requires a highly skilled surgeon and commonly results in bone fractures and infection.

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