Safety Warnings Regarding Stryker Rejuvenate and ABGII

Just this last April Stryker Orthopedics issued a safety bulletin to doctors and hospitals regarding two hip implants, the Rejuvenate and the ABGII. The bulletin listed the potential for excessive metal debris and metal ion generation in these hip implants, stating this could lead to extreme levels of fretting and corrosion of the hip implant. When fretting and corrosion occur in hip implants, the patient will usually have to undergo revision surgery which is both risky and complex. Additionally, when the metal ions which have been generated from the hip implant shear away from the device, they may either become lodged in the surrounding tissues or can enter the bloodstream. Either of these can cause serious health issues for the implant recipient.

Other Issues Related to the Safety Bulletin

Further, patients who have a heightened sensitivity to these metal ions could have an allergic reaction which causes the tissue surrounding the hip to become inflamed and painful. Stryker listed certain factors which could increase the risk of the metal ions including femoral offset, ph factors of the individual, excess weight of the implant recipient and patient diabetes or infection. When the femoral has too much offset, there will be greater bending motions at the taper junction as well as between the neck and stem.

Metal-on-Metal Components

While not considered metal-on-metal implants, the Stryker Rejuvenate and ABGII both have specific metal components. The neck of the Rejuvenate and ABGII are both made of cobalt and chromium, the stems of the implant are titanium-coated, and the metal-on-metal junction has the same potential to shear off metal shards as the true metal-on-metal implants.

How the Rejuvenate and ABGII Gained FDA Approval

Stryker issued a recall on the Rejuvenate and ABGII just three months following the safety warning. The recall was voluntary although the FDA had received numerous consumer reports of adverse health events from the Stryker hip implants. The FDA approval for the Rejuvenate came in June of 2008 while approval for the ABGII came in June of 2009. Both products were approved under the controversial 510(k) process which requires no clinical trials, only that the device or drug be substantially similar in nature to one which has already received FDA approval.

Unfortunately, this means that medical devices and drugs can gain approval based on a device which has suffered its own problems. In fact, the Rejuvenate approval was based on the Wright Profemur which has been found to have an extremely high rate of failure. When no clinical trials are required, in essence those who receive the implants or take the drugs are testing the safety and efficacy of the product. This type of safety testing can be very hazardous to the health of these people and the vast majority of recipients are never told of any potential dangers. Although the failure rate of the Rejuvenate and ABGII have not yet been determined, it is possible those rates may be very high.

Medical Issues Related to Metal Toxicity

When patients develop metal toxicity they may be subject to cardiovascular problems, kidney issues, thyroid problems, gastrointestinal issues along with an entire litany of less serious—but no less alarming—health issues. Many people with metal-on-metal hip implants have noted balance issues, hearing and vision disturbances, memory problems, and even the inability to distinguish between sweet and salty tastes. In cases where the metal ions lodge in the surrounding tissue, severe inflammation and chronic pain can result. The tissue can become damaged, diseased and may even die. When this type of tissue damage occurs, it will likely be necessary for the patient to undergo revision surgery.

When Revision Surgery is warranted

Although these types of hip implants were intended to last from fifteen to twenty years, many implant recipients have found that after only two to three years their hip implant has suffered total failure. Revision surgery can be risky as the neck portion of the Stryker Rejuvenate and ABGII is implanted deeply into the femur bone. When it must be removed, it can be necessary to cut away the bone, sometimes cutting significant bone length. The patient may suffer infection following the revision surgery, severe pain, and can end up with extremely limited mobility. Some patients have even found themselves in a wheelchair for the remainder of their life as a result of the revision surgery and the failed hip implant.

Legal and Medical Help for Victims of Stryker’s Rejuvenate or ABGII

If you have suffered fretting and corrosion of your Stryker Rejuvenate or ABGII which led to adverse health effects, you must first visit with your physician and take care of your health. Your physician will discuss your options and together you will decide whether a revision surgery is necessary. At the least your physician will likely want to begin monitoring the levels of metal in your body in order to ensure those levels are not unduly high. Following your doctor visit, an experienced Stryker hip implant lawyer should be your next stop.

In many cases your implant may not have failed yet, but could have a significant risk of failure. Because of the metal components, you may develop metal toxicity which can negatively alter your health and your future. There is a statute of limitations in all states which limits the amount of time you have in which to bring suit against a company who has put your health at risk. It is better to explore your options now rather than to wake up down the road sick and with substantial medical bills, yet unable to receive compensation from the manufacture of a defective product. 

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