Stryker Rejuvenate Recall

Risks Associated With the Stryker Rejuvenate Modular Hip System

Recently, Stryker has announced the recall of its hip implant modular system. While the Stryker Rejuvenate Modular Hip design has a lot of advantages, like a greater capacity for matching of proximal femoral version, offset, and limb length, there is the increased potential for neck-body dissociation and increasing amounts of metal debris generated and deposited in the device.

Studies show crevice corrosion are clinical issues with dual modular components. Corrosion remains the main issue in the failure of modular implants and is caused by multiple mechanisms – crevice corrosion, fretting corrosion, and galvanic corrosion.

Corrosion products from the modular interface can cause an inflammatory response which results in a local reaction. This metallosis, which is an adverse local tissue reaction, can ultimately affect the entire body. While the metallic ions can be dissolved in the body fluid and eliminated from some patient’s bodies, many patients have developed a range of adverse reactions, including:

  • Osteolysis (bone dissolution)
  • Synovitis (inflammation of the synovial membrane)
  • Pseudo-tumors
  • Fluid in the joint
  • Tissue and bone necrosis
  • Hypersensitivity to metal
Adverse reactions that affect the entire body include:
  • Decreased total lymphocyte cells, which defends against tumors and virally infected cells
  • Decreased CD8+T cells, which fight intracellular pathogens and malignancies
  • DNA changes
  • Chromosomal aberrations

Long-term toxicity of metal particles is not well known, but doctors have expressed concerns about the exposure to high levels of cobalt and chromium ions and there are numerous reports showing significant effects on organs away from the articulation. These ions are heavy metal ones that have been linked to serious illnesses. There are isolated case reports on a small number of patients in which high levels of metal ions in the bloodstream may have caused other types of symptoms or illnesses elsewhere in the body, including effects on the heart, nervous system, and thyroid gland.

We know from our work on other Metal-on-Metal joint implants that the exposure to heavy metals such as cobalt and titanium is a very real concern for patients.

If you or a loved one has had a negative reaction from the implant or feel you need to seek legal counsel, please call us right away (800-390-6600), email us or fill out our contact form for a Free Consultation with one of our attorneys.