PIONEERS IN MEDICAL DEVICE LITIGATION EXPERIENCED HIP RECALL ATTORNEYS
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STRYKER HIP RECALL
CONCERN OVER THE REJUVENATE & ABG II MODULAR-NECK HIP STEMS HIP IMPLANT COMPONENT
Unlike typical hip implant systems, which include a one piece neck and stem, Strykerâ€™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.
THE REJUVENATE HIP
ABG II SYSTEM Supposedly offers stability and minimal bone stress Sizing Options
Marketed to younger patients who were promised longer lasting devices that offered a better range of motion
(8 right, 8 left)
COMPLICATIONS Heavy Metal Poisoning (Metallosis) “tryker’s i pla ts are ade usi g Chro iu a d Cobalt, two Heavy Metal Compounds. When a device fails, these metal compounds can release metal ions and metal fragments into 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’S NO CURE FOR HEAVY METAL POISONING
Damaged Bone Structure (Osteolysis) In faulty implants, the various parts in the imp,lant 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 loose density and become more brittle resulting into cracked bones, fractures, pain in the hip, difficulty walking or difficulty sitting. YOUR BONES CAN LOOSE DENSITY
AND BECOME MORE BRITTLE
Tissue Destruction (Necrolysis) Tissue destruction can be caused by metal ions and metal fragements breaking off into the surrounding tissue. The tissue dies i side the ody, ut is â€™t always successfully broken down by body. Often time the dead tissue has to be removed by a surgeon during revision surgery.
MIGHT NEED REVISION SURGERY
Thickening of blood (Polycythemia Vera) Blood thickening is caused by primarily 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.
HEADACHES , DIZZINESS AND FATIGUE PARALYSIS, LOSS OF BALANCE AND EVEN STROKE
Inflitration of Lymphocytes Heavy metals can cause or increase risk of cancer in the number of different ways. Both cobalt and hro iu a i terfere with ellâ€™s a ility to repair DNA, resulting in a higher likelihood of mutations. One particularly dangerous effect of chromium is the possibility of lymphocyte infiltration
CAN TURN INTO A TUMOR
THE STRTYKER FAILURE TIMELINE April 14, 2008 Stryker submits the stryker Rejuvenate Modular Hip syste ’s 5 k to the FDA
August 21, 2009 Stryker submits the Stryker ABG II Modular-Neck “te ’s 5 k to the FDA
February 2010 Stryker begins marketing the Rejuvenate Modular Primary Hip System to doctors and medical facilities
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.
June 3, 2008 The FDA approves the application, based on a determination that the Stryker Rejuvenate was substantially similar to an existing product.
October, 2009 The FDA approves the application, based on a determination that the Stryker ABG II was substantially similar to an existing product.
April 2012 “tryker issues a Urge t “afety Alert i for i g doctors of the potential side effects of using the Rejuvenate system.
Recalled Stryker Hip Products? IMAGING Your surgeon may choose to perform certain imaging on your hip, including Xrays, MRIs, or Ultrasound. These forms of diagnostic imaging may help your surgeon in evaluating your hip.
BLOOD TEST 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 bacause the stem components of a hip implant are driven deep into the patie tâ€™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 Stryker hip recall lawyer immediately to protects your rights.
Talk with our attorneys to learn more about the Stryker hip recall and your legal rights: (888) 424-5757 www.rosenfeldinjurylawyers.com
Joost Smulders www.flickr.com/photos/79090030@N07/7525917668/sizes/l/in/photostream/