RECALL OF REJUVENATE AND ABG-II HIPS
On July 4, 2012, Stryker Orthopaedics recalled two of its hip implant products – the Rejuvenate and ABG-II. These two devices are what are known as modular-neck stem systems, meaning that the femoral component of the hip implant (the “stem”) is actually made of two separate pieces – the stem and the neck. The neck is supplied in a variety of lengths and angles which allows surgeons to conform the implant to a patients anatomy during surgery. In theory, this could be a good idea. The problem is that the neck is made of Cobalt-Chromium, and the stem is made of a special type of titanium called TMZF. The joint between these two kinds of metal results in fretting, corrosion and the release of metal particles into the blood stream and surrounding tissues. The presence of these metal particles initiates a foreign body response by the immune system, but the body has difficulty “cleaning up” the metal particles. What results is an inflammation cascade leading to adverse local tissue reactions and benign tumors.
Adverse symptoms caused by the Stryker Rejuvenate and ABG-II modular-neck stem systems include:
- High levels of metal ions in the blood
- Bone damage
- Loosening of the prostheses
- Benign tumors (pseudo-tumors)
- Pain surrounding the implant
- Adverse Local Tissue Reactions
- Tissue death
STRYKER HIPS ARE WORSE THAN THE OTHERS
Lately, manufacturers of so-called “meal-on-metal” hip implants have been facing lawsuits due to their products failing at very high rates and causing patients to undergo a revision surgery to replace the defective implants. In most metal-on-metal implants, the ball and socket joint is the problem and is where the metal-on-metal bearing surface is located (like in the DePuy ASR and Pinnacle, Biomet M2a, and the Smith & Nephew R3). Although a revision surgery for those implants is very serious, surgeons usually don’t have to replace the femoral stem. But the Stryker Rejuvenate and ABG-II modular-neck stem systems are different. Because, the metal-on-metal bearing surface is in the neck stem itself, the entire femoral stem may need to be replaced, and that means dislodging the stem from the femur.
STRYKER FAILED TO DO SUFFICIENT TESTING
One would think that Stryker could have figured this problem out with sufficient testing. But sufficient testing was not done. Stryker was able to push the Rejuvenate and ABG-II systems to market through a loophole in the FDA approval process. Through the so-called 510(k) abbreviated process, a company need only show that its product is substantially equivalent to another product already on the market. Stryker used the Wright Pro-Femur as the predicate device for its Rejuvenate and ABG-II modular-neck stems. However, the Pro-Femur has already had serious problems with corrosion and fractures of the prosthesis. Not surprisingly, the Rejuvenate and ABG-II systems are now having significant problems.
Have questions about your hip implant? We can help. If you are in pain or worried about your health or the wellbeing of a friend or loved one with a defective hip, it’s time to speak up and hold Stryker accountable.
WHAT YOU CAN DO
Call your doctor. You can have your chromium and cobalt levels tested to determine if the device is functioning properly.
Call attorney Todd Romano at Romano Law Group. If you or someone you know has a Stryker Rejuvenate or ABG-II hip implant and is suffering from or has experienced persistent side effects, the Romano Law Group can provide you with more information about what you can do. Some people may not even know what kind of hip implant they received – and that is okay. If you or a loved one are having problems with a prosthetic hip, we can help you determine what kind of hip you have and if we can help you pursue a case.
Lawsuits against Stryker have already been filed around the country. Take your first step toward a pain-free life and give us a call.