Stryker Hip Recall

Stryker Hip Recall – Rejuvenate And ABG II

The U.S. Food and Drug Administration (FDA) approved the Stryker Rejuvenate model in June 2008 while the ABG II model was approved in November 2009. In July 2012, Stryker Corp. issued a voluntary recall for both the Rejuvenate and ABG II models. This recall came just a few months after Stryker issued an “Urgent Safety Alert” to surgeons about the hazards linked with these two devices.

Both designs have been associated with complications, including loosening of the implant and metallosis (metal poisoning). Due to complications, many patients with a Stryker hip have had to undergo hip revision surgery.

Both recalled Stryker models include metal neck and stem components that have a tendency to grind together. The friction produced can cause metal debris to loosen and detach from the hip devices into the bloodstream. The release of these chromium and cobalt ions into the bloodstream can build up over time and result in metallosis, also known as metal poisoning. While the full effects of metallosis are still relatively unknown, this condition is serious and all those who believe that they have a Stryker hip implant should undergo routine diagnostic testing such as imaging and blood work to monitor the implants’ condition.

Symptoms Commonly Associated With Elevated Cobalt/Chromium:

  • Impaired kidney function
  • Loss of vision and hearing
  • Thyroid problems
  • Fatigue
  • Anxiety
  • Depression
  • Chronic short-term memory loss
  • Recurrent headaches
  • Dizziness and vertigo
  • Skin disorders
  • Gastrointestinal disorders
  • Development of pseudotumors

It was recently estimated that the recalled Rejuvenate and ABG II models could potentially have a failure rate as high as one in three, meaning that as many as 33 percent of the nearly 30,000 units sold in the United States could ultimately fail. The Rejuvenate and ABG II devices were originally marketed to younger patients because they offered an increased range of motion, better fit and subsequently longer lifespan than the typical 15 to 20 years commonly expected with most hip implants. However, many of our clients began experiencing symptoms commonly associated with a failing implant within 18 months after their initial procedure and often have had to undergo revision surgeries within two to three years.

Symptoms Commonly Associated With A Failing Rejuvenate/ABG II Implant:

  • Intense pain
  • Bone deterioration
  • Clicking or squeaky noises
  • Inflammation/swelling around the hip
  • Difficulty walking up stairs
  • Difficulty with hip flexion
  • Groin or thigh pain
  • Metallosis
  • Spontaneous dislocation

Adverse Side Effects Can Include:

  • Metallosis (a buildup of metallic debris)
  • Necrosis (the cell death of affected tissue)
  • Osteolysis (the death of bone cells due to blood supply issues)
  • Loosening of the implant

Revision surgery for a failed Rejuvenate or ABG II hip is a complicated procedure in which the entire femoral stem is removed and replaced with another, larger metal stem. Because the stem is inserted down the center of the femur bone, removal is fairly traumatic and often results in fractures of the femur itself, which then must be repaired with more metal hardware. The result is a difficult and prolonged recovery process, with a higher likelihood of permanent loss of hip function.

FDA News Release: Stryker Initiates Voluntary Product Recall of Modular-Neck Stems

The Journal of Arthroplasty (Study): Pivec R, et al, Modular Taper Junction Corrosion and Failure: How to Approach a Recalled Total Hip Arthroplasty Implant, J Arthroplasty (2013)

Experience Matters

Sacramento attorney Brooks Cutter has been involved with hip litigation for nearly eight years and has represented clients nationwide. Brooks was selected as a member of the plaintiffs steering committee and co-chair of the Hip Discovery Committee for the multidistrict litigation in Ohio on behalf of people implanted with a defective Sulzer hip. In November 2013, he was selected as part of a small group of leading attorneys across the nation to guide proceedings in the multidistrict litigation involving the Stryker Rejuvenate Hip Implant.

Free Consultation: Contact Us Today

If you or someone you know has a Stryker metal-on-metal hip implant, you may be entitled to compensation.

Schedule a free case evaluation or call us at 916-461-8697.

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