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Stryker Hip Implant Lawsuit: ABG II and Rejuvenate

January 4th, 2013

Stryker Orthopaedics Corporation has issued a voluntary recall on its Rejuvenate Modular and ABG II Modular Neck Stems after post-distribution reports were issued stating that these implants are susceptible to corrosion and/or fretting, which can lead to metallosis, adverse local tissue reactions, and pseudotumors.

Arthroplasty, also known as a hip replacement, is the replacement of the diseased or deteriorated hip joints with a prosthesis to relieve pain and increase mobility and function in the hip. The Stryker Rejuvenate system is a device with a stem and neck designed to replace the patient’s hip by providing a mechanism that allows the joint to pivot as it would naturally. The Stryker ABG II Modular Neck Stem is a product designed to reconstruct the hip joint area by attaching inside the femur and coming out to connect with the hip.

Hip Replacement Risk

Standard risk to patients who receive hip replacements include decrease of bone mass or bone loss, nerve damage, uneven leg length, stiffness, and decrease in immune system function. Revision surgery is usually warranted in cases where the patient is experiencing post-surgical issues such as metal sensitivity, loosening of the implant, audible sounds from the area during movement and general wear over time.

Metal-On-Metal Implants

When metal pieces in hip implants constantly rub against each other, corrosion occurs. Unlike true metal-on-metal devices where the ball and socket are both made of metal components, both the AGB II and Rejuvenate products had metal stems and metal necks that rub together in a way similar to how the ball and socket devices do.

Metallosis

When corrosion or fretting occurs in metal hip implants made with cobalt and chromium metals, such as the Stryker Rejuvenate Modular and ABG II Modular Neck Stems, the patient can develop metallosis, a condition where metal debris collects in the soft tissues. This can cause inflammation and swelling, as well as destroy the otherwise healthy tissue surrounding the implant site. With deterioration of the tissue, the implant may become misaligned, causing severe pain, infection, swelling, and dislocations These complications can eventually necessitate a revision surgery.

Product Failure

While hip replacements are designed to withstand up to fifteen years of use, both the ABG II and Rejuvenate replacements began showing signs of failure after several months. This caused excessive post-surgical pain that required revision surgery in some patients.

Symptoms

If metallosis exists, inflammation and swelling of the area around the implant could occur, with some cases of pseudotumors and fluid in the joint. Tissue damage from metallosis can present as a rash in the affected area. An often overlooked sign of metallosis is extreme pain, which many patients dismiss as after-effects of the replacement. Metallosis can also cause the levels of cobalt and chromium metals in your blood to elevate. In some cases, this elevation of metal levels can be toxic and cause many systemic illnesses.

Further side-effects of metallosis include the following:

  • Confusion
  • Dizziness
  • Headaches
  • Recurring infections
  • Gastrointestinal issues
  • Malaise
  • Emotional imbalance

Patients who have either the Rejuvenate Modular or ABG II Modular Neck Stems should contact their doctor immediately. While not every patient who received Stryker’s ABG II or Rejuvenate products have experienced symptoms of metallosis or product failure, all ABG II or Rejuvenate recipients should contact their doctor.

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