Stryker Rejuvenate and ABG II Modular Hip System Recall

Stryker Rejuvenate and ABG II Modular Hip System Recall

June 23rd, 2014

Thousands of Americans receive hip replacements every year due to sports injuries, falls, aging and a host of other reasons. The goal of a hip replacement surgery is to return to your active lifestyle as quickly as possible. There are many different hip replacement medical devices on the market, from plastic implants to metal on metal implants.

Over the past decade, there have been a number of recalls on many of the top, name brand, metal on metal hip implant devises. It is the FDA’s duty to be the guardhouse for safe products, but sometimes defective products are passed through the system due to inadequate testing, manipulated reporting and of course, from human error.

Stryker is letting patients know that they should undergo a hip revision surgery to replace their metal on metal hip device for another model. Stryker will cover the cost of the revision surgery, but there is more to having a revision surgery then the procedure alone. There is prep time, the surgery itself, the recovery time and the hopes that the revision surgery will go well and not create any further medical problems.

Unfortunately, sometimes, medical devices and pharmaceutical drugs get fast tracked through the system, meaning the FDA approves them for market use, before enough research and testing has been conducted.

This is what happened with many metal on metal hip implant devices. The FDA approved them all, but as they were used, more and more adverse reaction reports were being sent to the FDA, so an investigation began. Usually this takes years for a medical device or prescription drug to be recalled off the market. And while the FDA waits, innocent patients continue to be harmed.

Over two years ago, on July 6, 2012 Stryker issued a voluntary recall of its Rejuvenate and ABG II modular-neck hip stems due to the increased potential for neck-body dissociation and increasing amounts of metal debris generated and deposited by the device.

Long-term toxicity of metal particles is not well known, but doctors have expressed concerns about metal exposure and there are numerous reports showing significant effects on organs. Metal toxicity has been linked to serious illnesses and is a very real concern for patients.

The modular interface of the Rejuvenate and ABG II creates corrosion, causing an inflammatory response, which results in a local reaction, such as metallosis, eventually affecting the entire body. Many patients have suffered a range of adverse reactions, such as:

  • 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

If you have a Stryker Rejuvenate or Stryker ABG II implant and require a revision surgery call The Yost Legal Group at 1-800-YOST-LAW (1-800-967-8529). We’ll speak with you for free to discuss your situation and help you to understand your rights.

If we take your case we will do so on a no win/no fee or expense basis only. That means you do not pay a fee or expense unless you recover.

Call now for a free confidential consultation.

The Yost Legal Group, Experienced Lawyers Dedicated to Protecting your Rights.

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