Stryker Hip Replacements
Hendler Lyons Flores – filing hip recall lawsuits for patients injured by Stryker Rejuvenate or ABG II hip implants
- Stryker Rejuvenate and Stryker ABG II hip replacement systems: what’s wrong with them? The two metal components in Stryker’s "revolutionary" modular-neck stem rub against each other, releasing dangerous metal ions capable of causing serious injuries and requiring additional surgery. More… [jump to NYT Reports section]
- When did Stryker recall its Stryker Rejuvenate and Stryker ABG II hip replacement systems? Though Stryker received serious complaints about its Rejuvenate and Stryker ABG II hip replacement systems in 2011, the company waited to recall the hip implants until July 2012. More… [jump to timeline section]
- What injuries are caused by Stryker’s Rejuvenate and ABG II hip implant systems? One of the two metal mix-n-match components that Stryker used in its modular hip systems was made of chromium and cobalt and the other was coated in titanium. When these metal parts rub against each other, they can release metal ions in your body, causing:
Stryker's Rejuvenate and ABG II Hip Implant Systems: Metal-On-Metal Components Pose Dangerous Risk
Remember when you were younger and "heavy metal" meant rock bands with loud guitar, as opposed to metal ion levels in your bloodstream on account of your metal hip implant? From your current vantage point, those young men with their frequently unfortunate haircuts – and the years when you didn’t even notice your hips were there – are probably looking pretty good.
This is especially true if you are among the thousands of people suffering complications from the implant of a Stryker Rejuvenate or a Stryker ABG II hip replacement system. The Stryker hip implants were supposed to be a revolution in the hip replacement market. Instead of the usual one-piece stem and neck "monoblock" design, the new Stryker hip system came with a two-piece neck and stem design that offered more variations than your local supermarket has Ben & Jerry’s flavors. In theory, the mix-n-match metal components would give greater stability and minimize stress on the bone. The all-metal neck and stem were said to afford longer wear and tear.
The ABG II system offered eight stem options and ten modular necks from which your surgeon could choose to find the configuration that conformed best to your body. The Rejuvenate hip, with its six stem choices and sixteen necks, was promoted for younger, more active patients who were assured the customized hip would last longer and provide a fuller range of motion for what you may have envisioned as a glamorous retirement full of tennis, golf, hiking and Zumba.
Now that the surgery’s over, however, the pain is so excruciating that all you want to do is haul your new Stryker hip up off of the sofa to walk into the kitchen for some of that ice cream. Now it looks as though your freezer may be the closest you’re going to get to hiking in snow-capped mountains. What went wrong?
The problem with the Stryker Rejuvenate and ABG II hip systems is in the two modular components – the neck component is made from chromium and cobalt and the stem component is covered with titanium. As these metal parts wear against each other over time, tiny metal particles can be released into your body, causing metallosis, necrosis and osteolysis. Many people actually require "replacement" replacement hip surgery, called revision surgery.
In February 2014, the New York Times reported on two severe cases of metallosis discussed in two prominent medical journals – The New England Journal of Medicine and The Lancet. In one case, a man in Germany with a metal-on-metal hip replacement had cobalt levels so high that his heart could barely pump enough blood to keep him alive and he became nearly blind as well as practically deaf. A Denver woman actually was forced to undergo a heart transplant as a result of cobalt poisoning caused by her metal-on-metal hip implants. Though cases this severe may be unusual, they highlight the serious danger of metallosis from hip systems containing metal-on-metal components, like Stryker’s Rejuvenate and ABG II.
The basic sequence of events for Stryker’s Rejuvenate and ABG II Hip Replacements went like this:
- In 2008, Stryker received FDA approval to begin sales of its Rejuvenate hip system; in 2009, approval to sell the ABG II system was given. Stryker conducted no clinical trials on these products to determine whether they were safe or whether they even worked. (Starting to feel a bit like maybe you’re the lab rat in this picture?)
- In 2009, Stryker sales of the Rejuvenate hip implant began and in 2010, the ABG II hip system was introduced to the market.
- By 2011, Stryker and the FDA began to receive complaints about the modular-neck hip implants, including reports of dislocation, pain, swelling, immobility, loosening of the implant and premature hip device failure requiring revision surgery to replace the replacement.
- In February 2012, the British Medical Journal published an article warning that some metal-on-metal hip implants could send metal ions into the joint area surrounding the hip implant and into the patient’s bloodstream at levels that could actually destroy muscle tissue and bone.
- In April 2012, Stryker notified physicians, in an "Urgent Safety Alert," of the potential dangers associated with the ABG II and Rejuvenate systems, explaining that the two metal components in the modular-neck stem could rub against each other and release metal ions that could cause "metallosis, necrosis, and/or pain," as well as "the need for revision surgery."
- In May 2012, Health Canada announced a recall of some Rejuvenate modular-neck hip components to allow the implantation instructions to be updated.
- Finally, in July 2012, Stryker voluntarily recalled its Rejuvenate and ABG II modular-neck hip replacement systems. The manufacturer recommended that patients who had received either of its hip systems should contact their physicians. According to Stryker, patients experiencing pain should be screened with X-rays, MRIs and blood tests to detect excessively high metal ion levels.
Injuries Caused by Stryker's Rejuvenate and ABG II Hip Implant Systems
One of Stryker’s purported selling points for its Rejuvenate and ABG II hip implants was that unlike metal-on-metal hip replacement systems, Stryker’s system incorporated a ceramic ball that was supposed to prevent the health risks caused by implants using a metal ball that rubs up against a metal socket. Hmm, you might wonder, what about the two metal components that made the revolutionary Stryker "modular-neck" modular – the neck component made from chromium and cobalt and the accompanying stem component coated in titanium? What about that metal-on-metal joint in the Rejuvenate and ABG II hip implants?
It turns out that just like the metal-on-metal joint in other manufacturers’ hip systems, the metal-on-metal joint in Stryker’s modular neck is susceptible to corrosion caused by the friction of the two metal components rubbing against each other. The Stryker Rejuvenate and ABG II systems can corrode at either end – where the neck is placed into the ball or where the stem is inserted into the femur. In both locations, microscopic metal particles can shear away from the hip replacement system, resulting in metallosis, the escape of metal ions into the tissue and bloodstream.
Necrosis and Osteolysis
So, what’s the big deal with the heavy metal ions pulsing around in your tissue and bloodstream instead of banging their heads on stage where they belong? Well, as Stryker put it in that April 2012 "Urgent Safety Alert" to surgeons, there’s necrosis (where body tissue turns gray and then dies prematurely), osteolysis (where the body’s attacks on the stray metal particles cause inflammation, pain and the loss of bone around the implant); and, loosening of the hip implant due to the loss of tissue and bone (which requires revision surgery).
Revision surgery is a very polite, and thus grossly misleading, term for what happens when the Stryker Rejuvenate or ABG II system has to come out. Most people would rather sit through a thousand heavy metal concerts back-to-back than go through it. During the surgery, the entire femoral stem has to be taken out and replaced with an even bigger metal stem. The removal process is extremely difficult and often causes fractures to the femur. When that occurs, the break must be fixed with even more metal hardware. The recovery process is long and complicated, and carries the potential for a complete loss of hip function.
Stryker Rejuvenate and ABG II Hip Recall Lawsuits
Patients from around the country have experienced horrific pain caused by Rejuvenate and ABG II hip implants and have suffered the serious consequences associated with revision surgery to remove and replace Stryker’s hip systems. Many of these patients have turned to the courts for justice. Patients injured by a Stryker Rejuvenate or ABG II hip replacement have substantial rights in most states. These rights include entitlement to fair compensation for medical expenses (including the cost of revision surgery), lost wages (past and future), pain and suffering and punitive damages.
Consolidation of Federal Stryker Rejuvenate and ABG II Lawsuits: What Does It Mean?
In June 2013, the U.S. Judicial Panel on Multidistrict Litigation consolidated all federal Stryker Rejuvenate and ABG II lawsuits into the U.S. District Court of Minnesota to streamline the process for pre-trial proceedings. When cases are consolidated this way, you are still represented by your own chosen lawyer, who ensures that your interests are safeguarded during the lawsuit. Should your case proceed to a jury trial, it would be transferred back to the court in which it was filed originally and your personal injury lawyer would try your case. The purpose of consolidation is just to save resources by having one judge decide all the issues that the individual cases around the country have in common. In many instances, the consolidation actually speeds up the process.
Hendler Lyons Flores: Helping Patients Injured by Stryker Rejuvenate and ABG II Hip Implants
If you have experienced pain and other complications after receiving a Stryker Rejuvenate or ABG II hip replacement system, contact our office today. We’re here to listen as well as to help you learn more about your legal options. Let us use our years of experience with dangerous product cases to help you recover the legal compensation you deserve. Grab a little dish of ice cream, or just a cup of coffee, and call us any time day or night at 1-800-443-6353 for a free consultation. We promise not to put you on hold with heavy metal.
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