Risk of Metallosis from the Smith and Nephew R3 Acetabular System

Like many other metal-on-metal hip implant systems, the Smith and Nephew R3 has the same potential for causing metal ions to shear away from the implant, for lodging into surrounding tissues and the bloodstream, and for causing serious health issues such as metallosis. The metal liner of this particular model was recalled voluntarily by Smith and Nephew this past June. The Smith and Nephew R3 system was brought to the U.S. in 2009 and it is estimated that over 7000 of the recalled liners made from cobalt and chromium have been implanted in recipients. Smith and Nephew currently maintain a 12.1 percent market share among manufacturers of hip implants.

The R3 Acetabular System is still being sold, however the company has expanded the model to include plastic, metal or ceramic cups, zirconium, ceramic or cobalt femoral heads, and, following the recall of the metal liner, they are offering zirconium or polyethylene plastic liners.  The Smith and Nephew R3 becomes a true metal-on-metal hip implant when used with a metal liner. The metal liner of the R3 is made of cobalt and chromium which are toxic and have even been linked to DNA alterations and damage. The metal ions which shear away from the R3’s metal components can lodge in the tissues causing pain, tissues loss and tissue necrosis, bone deterioration, and severe inflammation.

When significant amounts of bone and tissue have died or deteriorated, the implant is in danger of failing completely as it pulls away from the femur. These complications can lead to metallosis, also known as metal poisoning or metal toxicity. Although a study done by Australia’s National Joint Replacement Registry found little evidence of metallosis in patients implanted with a Smith and Nephew R3 with a metal liner, those same patients did experience significant levels of allergic reactions or sensitivities and other complications which can, in turn, lead tometallosis. Metallosis symptoms can be relatively mild, or can be severe. The longer the metal components are in the body, creating metal ion shear, the levels of cobalt and chromium will continue to accumulate in the body, leading to ever-worsening symptoms.

The symptoms of metallosis can include the following:

  • Neurological, cardiovascular, renal and thyroid problems
  • Gastrointestinal disorders
  • Skin disorders
  • Memory loss
  • Balance problems
  • Dizziness
  • Hearing and vision disorders
  • Pseudo tumors

A patient who has a Smith and Nephew R3 Acetabular System with a metal liner—or any other metal-on-metal hip implant—must have regular blood tests done to check levels of cobalt and chromium and must report any pain or other symptoms of metallosis to their doctor immediately. Additionally, it can be advantageous for the recipient of an all-metal hip implant to speak with a products liability attorney regarding their rights. 

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