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Stryker Hip Recall

STRYKER HIP RECALL CONCERNS OVER THE REJUVENATE & ABG |I MODULAR-NECK HIP STEMS HIP IMPLANT COMPONENT Unlike typical hip implant systems, which include a one-piece neck and stem, Stryker's Rejuvenate and ABG II systems include several neck and stem components. The systems were designed to give surgeons greater flexibility by offering them more anatomically correct implant components that could be custom-fitted to patients. Neck Stem ABG II SYSTEM THE REJUVENATE HIP Supposedly offer greater stability and Marketed to younger patients who were minimal bone stress promised longer-lasting devices that offered a better range of motion Sizing Options 16 (8 right, 8 left) Stem 10 16 Neck COMPLICATIONS Heavy Metal Poisoning (Metallosis) Cr Stryker's implants are made using chromium and cobalt, two heavy metal compounds. When a device fails, these metal compounds can release metal ions and metal fragments into the surrounding tissues and blood stream, causing pain or inflammation of the tissue. More severe cases can cause internal bleeding, gastrointestinal issues, increased risk of cancer and even patient death. There is no cure for heavy metal poisoning. Damaged Bone Structure (Osteolysis) In faulty implants, the various parts in the implant can loosen and subtly push into the underlying bone structure. This causes Osteolysis, where the calcium in the bone fluids starts to get drained off. The calcium is broken down and re-absorbed by the body through the blood stream. Then your bones lose density and become more brittle. That can cause all kinds of other health issues and complications, including cracked bones, fractures, pain in the hip, difficulty walking or difficulty sitting. Tissue Destruction (Necrolysis) Tissue destruction can be caused by metal ions and metal fragments breaking off into the surrounding tissue. The tissue dies inside the body, but isn't always successfully broken down by body. Often time's the dead tissue has to be removed by a surgeon during revision surgery. Thickening of Blood (Polycythemia Vera) Blood thickening is caused primarily by cobalt poisoning, which can result from metallosis. In a person with polycythemia vera, the red blood cell count in the blood gets inflated. This causes the blood to thicken and become sluggish. In mild cases, this can cause headaches, dizziness and fatigue. In severe cases, this can result in paralysis, loss of balance and even stroke. Infiltration of Lymphocytes Heavy metals can cause or increase risk of cancer in the a number of different ways. Both cobalt and chromium can interfere with cells' ability to repair DNA, resulting in a higher likelihood of mutations. Chromium on its own can cause DNA mutations. One particularly dangerous effect of chromium is the possibility of lymphocyte infiltration. This is where white blood cells leave the blood stream, plant themselves in the body then multiply and turn into a tumor. Chromium has the risk of causing lymphocyte infiltration in the areas around the implant. THE STRYKER FAILURE TIMELINE April 14, 2008 Stryker submits the Stryker Rejuvenate Modular Hip System's 501(k) to the FDA. June 3, 2008 The FDA approves the application, based on a determination that the Stryker Rejuvenate was substantially similar to an existing product. August 21, 2009 Stryker submits the Stryker ABG |I Modular-Neck Stem's 501 (k) to the FDA. October 2009 The FDA approves the application, based on a determination that the Stryker ABG II was substantially similar to an existing product. February 2010 Stryker begins marketing the Rejuvenate Modular Primary Hip System to doctors and medical facilities. April 2012 Stryker issues an "Urgent Safety Alert" informing doctors of the potential side effects of using the Rejuvenate system. July 6, 2012 Stryker issues a voluntary recall of all Rejuvenate and ABG II devices sold in the United States. A voluntary recall means it was issued by the manufacturer, though most recalls are also done with the help and cooperation of the FDA, DANGEROUS SIDE EFFECTS RECALL HAVE A RECALLED STRYKER PRODUCT? What You Should Do IMAGING Your surgeon may choose to perform certain imaging on your hip, including X-rays, MRIS, or Ultrasound. These forms of diagnostic imaging may help your surgeon in evaluating your hip. BLOOD TEST RESULT To check for dangerously high heavy metal (chromium, cobalt & titanium) ion levels that may have become absorbed by the body. HIP REVISION Hip revision surgery may be necessary in some patients with adverse local tissue reaction or ongoing pain. A revision surgery requires the replacement of the metal hip with a ceramic-on-metal modular junction replacement. Stryker hip revision surgeries can be difficult for the patient because the stem components of a hip implant are driven deep into the patient's femur-- requiring a quite a bit of force to remove. Some revisions may result in femur fractures as the hardware is removed. SPEAK TO AN ATTORNEY As a recipient of a defective medical device, you may be entitled to pursue a claim for monetary damages from the manufacturer. The law has specific time constraints for filling a lawsuit. You may wish to talk to a lawyer immediately to protect your rights. Learn more about your legal rights related to these defective Stryker hip products by visiting Sources: | | Sponsored by Rosenfeld Injury Lawyers created by MilkWhale

Stryker Hip Recall

shared by rosenfeldj on Jan 31
Stryker Hip Recall - Concerns over the rejuvenate & AGB II Modular-Neck Hip Stems


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