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Stryker Hip Recall: Concerns over the Rejuvenate and ABG II Modular-Neck Hip Stems
Most hip implant systems have a neck and stem comprised of a single piece. The Stryker’s Rejuvenate and ABG II systems were meant to give hip replacement surgeons more flexibility by providing several neck and stem pieces in order to make a more anatomically correct implant for each patient.
The ABG II system was purported to have more stability while providing lower bone stress. It came with 16 stem sizing options and 10 neck sizing options while the Rejuvenate had 6 stem options and 16 neck options. The Rejuvenate was intended for younger patients that wanted more range of motion and a longer-lasting appliance.
Medical Dangers of Stryker Hip ReplacementsMetallosis
One major concern is that the Stryker implants are constructed using cobalt and chromium. As the device deteriorates, heavy metal poisoning can occur, resulting in pain and inflammation. Patients with more severe cases of heavy metal poisoning can experience internal bleeding, gastrointestinal problems, higher cancer rates and even death. Metallosis has no cure.Osteolysis
Osteolysis, or damage to the bone structure, occurs when a defective implant begins to loosen and drive into the underlying bones. As the condition progresses, the calcium in the bone fluids filters into the bloodstream, where it is re-absorbed into the body. Patients will lose bone density and the bones will become brittle. People with osteolysis will experience higher rates of fractures, bone cracks, hip pain or difficulty walking and sitting.Necrolysis
When metal ions and fragments enter nearby tissues, tissue destruction or necrolysis occurs. Interior tissues start to die but the body doesn’t always break down and dispose of them. Surgery is generally required to remove the dead tissue.Polycythemia Vera
Cobalt poisoning is responsible for polycythemia vera. The red blood cell count goes up which results in thick blood and slow blood flow. Patients with polycythemia vera report headaches, fatigue and dizziness. Paralysis, loss of balance and stroke are notable among patients with more severe blood thickening.Lymphocyte Infiltration
There are many reasons why heavy metals increase the risk for cancer. Cobalt and chromium are known to hinder cells’ capacity to repair DNA. This leads to an increased risk of mutation. Chromium is particularly dangerous. It will cause DNA mutations and it can also cause lymphocyte infiltration. Lymphocyte infiltration happens when white blood cells leave the blood stream for other parts of the body. Once implanted in other tissues, they can form a tumor, which will often be found near the implant.History of Stryker Implant Failures
Stryker submitted the Rejuvenate Modular Hip System for FDA approval on April 14, 2008. The FDA approved the application on June 3, 2008, ruling that the Rejuvenate was similar to another approved product. On August 21, 2009, Stryker submitted the application for the ABG II model which was approved in October of 2009. Marketing began for the Rejuvenate in February 2010.
More than two years later, in April 2012, Stryker released an “Urgent Safety Alert” about likely side effects of the Rejuvenate hip replacement. A voluntary recall of all ABG II and Rejuvenate products sold in the United States was issued on July 6, 2012.What You Should Do if You Have a Recalled Stryker Hip Replacement?
The first thing is to ask your surgeon to take an image of your hip replacement – either X-ray, MRI or Ultrasound to evaluate the hip. Also get a blood test to look for dangerously high levels of heavy metals. In the case of pain or adverse reactions, a hip revision surgery may be required. With Stryker products, surgery is often difficult because the implant is lodged deep within the femur. At times, a revision will result in a fractured femur. Be sure to speak to an attorney. Since you have received a faulty medical device, you could be eligible for damages.