Thursday, October 11, 2012

Potential for Fretting and Corrosion in Stryker Rejuvenate and ABG II Lead to Recall

A recent medical study by Carlson, et al (recently published in Volume 27, Issue 7 of the Journal of Arthroplasty) found that modular hip devices such as the Stryker ABGII and the Rejuvenate have a strong potential for corrosion damage at the head-neck junction. The study tested 78 of the implants which were recovered following revision surgery and evaluated them for fretting and corrosion of the metal parts. They found that the metal head were much more likely to suffer fretting and corrosion. When the metal-on-metal components rub against one another the resulting friction releases tiny metal particles of cobalt and chromium.

These microscopic metal shards can become lodged in the surrounding hip tissue or can enter into the bloodstream and lead to serious metal toxicity. In general, hip implant recipients who lead a more active lifestyle have a greater likelihood of metal toxicity. Paradoxically, the fittest patients are more apt to suffer severe and chronic pain as well as overall diminished quality of life following a metal-on-metal hip implant surgery. The study noted the highest levels of corrosion on the femoral stem; the level of corrosion on the head correlated closely to that of the neck taper in most cases.

The Stryker Safety Bulletin

The Stryker Rejuvenate and ABGII were voluntarily recalled this last July after a safety alert was issued to physicians and hospitals a few months earlier. Stryker’s safety alert warned of excessive metal debris and ion generation resulting from the Rejuvenate and the ABGII as well as excessive fretting debris. Stryker’s own bulletin states that affected patients could present with symptoms which are similar to those of infection, including chronic and severe pain and inflammation. Further into the safety bulletin Stryker lists specific factors which can increase the risk of corrosion and fretting and eventual metal toxicity. These factors include a femoral offset which leads to greater bending motions at the taper junction as well as individual factors such as diabetes and infection which could play a role in corrosion as well.

Health Risks of Metal Toxicity

While every recipient of a hip implant may have a different reaction to the accumulation of metal in the body, when levels are high enough negative health effects including cardiovascular, kidney, thyroid and even DNA disruption and damage. While not medically documented, others who suffer from metal toxicity have noted memory loss, hearing and vision disruptions, dizziness and balance problems, gastrointestinal issues and even the inability to distinguish between sweet and salty tastes.

The Metal-on-Metal Implant

Metal toxicity is a very serious issue and even though Stryker’s Rejuvenate and ABGII were not marketed as metal-on-metal hip implants, the necks are made of cobalt and chromium, the stems are coated with titanium and the metal-on-metal junction has the same likelihood of metal shards shearing off during activity as the true metal-on-metal ball and socket hip implants. It is very likely that metal-on-metal hip implants are the largest medical device failure in American history, affecting over half a million hip implant recipients. While many of these hip implant recipients have already suffered serious medical issues as a result of metal toxicity, still others will likely have adverse effects in the future.

Revision Surgery

While marketed as lasting fifteen to twenty years, there is a huge likelihood that the hip implant will have to be replaced in a complex and potentially dangerous revision surgery. Because the neck portion of the Stryker Rejuvenate and ABGII are implanted deeply into the femur, the revision surgery can require cutting away of the bone. Revision surgery can also lead to infection and potentially fatal sepsis. Many recipients of the Stryker hip implant who were forced to undergo revision surgery found themselves with extremely limited mobility following the surgery.

Getting Medical and Legal Help

If you or a loved one received a Stryker Rejuvenate or ABGII hip implant you should make an appointment with your physician even if you have not yet experienced any ill effects from the implant. Once you have taken care of your health, you should then consult with a knowledgeable Stryker hip recall attorney in order to have your case evaluated. Don’t find yourself somewhere down the road with serious health issues from a Stryker hip implant and no recourse because the statute of limitations has passed.

Author: Sullo & Sullo Attorneys

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