analysis of stryker rejuvenate recall from hip defect lawyers
DESCRIPTION
In July 2012 Stryker issued a voluntary recall of its popular Rejuvenate and ABG II hips following a stream of documented problems with the devices. For a hip prosthetic device that was intended to have a working life of 10-20 years, patients began experiencing high rates of complications and device failures that necessitated monitoring or a replacement of the device with a procedure known as a hip revision surgery. The area of the hip that is believed to be responsible for this complication is known as the ‘modular neck joint’ commonly referred to the ball and socket joint where the components from the device meet. The actual connection of the artificial joint is composed of metal-on-metal parts that have the propensity to wear on one another during normal use causing bits of the metal components to wear of and become embedded in the surrounding tissue. In the words of Stryker, the Rejuvenate and ABG IG hip systems have the “potential for fretting and/or corrosion at or about the modular neck junction, which may result in adverse local tissue reactions manifesting in pain and/or swelling.” For many patients the pain associated with this device and the complications associated with the ‘fretting’ has necessitated a second --- and far more invasive surgical procedure knows as a hip revision surgery. While performing a hip revision surgery, the device is removed and replaced with a different type of artificial hip. Unfortunately, the removal of the original device is painful and has the potential for serious complications such as the fracture of the femur due to the design of the stems in the Stryker products. As a result of these apparent design flaws, many people with these devices has initiated lawsuits against Stryker based on: • Design flaws • Failure to warn of complications • Deceptive marketing • Inadequate pre-market testing • Negligence in design and manufacturing techniques Rosenfeld Injury Lawyers is actively pursuing Stryker Rejuvenate and ABG II hip defect cases and is moving forward with the prosecution of these cases. If you are the recipient of one of these devices we encourage you to speak to one of our Stryker hip recall attorneys now—even if you are not presently experiencing any symptoms—so we can discuss the most recent updates and your particular situation. Our attorneys are committed to obtaining the most favorable recovery for each of our clients and we are prepared to litigate these cases for the long run. In anticipation of a protracted battle, our team has retained experts in the fields of: medical device design, FDA approval process, metal poisoning, rehabilitation and economics to ensure that our clients future needs are provided for. We welcome the opportunity to discuss your case with you without any cost or obligation on your end. Give us a call at (888) 424-5757 or visit or websites.TRANSCRIPT
PIONEERS IN MEDICAL DEVICE LITIGATION
EXPERIENCED HIP RECALL ATTORNEYS
www.rosenfeldinjurylawyers.com | www.strykerhipfaq.com | (888) 424-5757
Are you or your loved one
implicated by the
Stryker hip recall?
Are you aware of your
short-term and lifelong
medical / legal
rights?
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.
CONCERNOVER THE REJUVENATE & ABG II MODULAR-NECK HIP STEMS
Supposedly offers stability and minimal bone stress
ABG II SYSTEM THE REJUVENATE HIP
Marketed to younger patients who were promised longer lasting devices that offered a better range of motion
HIP IMPLANT COMPONENT
Sizing Options
Neck
16(8 right, 8 left)
10 6
16
Neck
Stem
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 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
COMPLICATIONS
Heavy Metal Poisoning (Metallosis)
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
Damaged Bone Structure (Osteolysis)
MIGHT NEED REVISION SURGERY
Tissue destruction can be caused by metal ions and metal fragements breaking off into the surrounding tissue. The tissue dies inside the body, but isn’t always successfully broken down by body. Often time the dead tissue has to be removed by a surgeon during revision surgery.
Tissue Destruction (Necrolysis)
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.
PARALYSIS, LOSS OF BALANCE AND EVEN STROKE
HEADACHES , DIZZINESS AND FATIGUE
Thickening of blood (Polycythemia Vera)
Heavy metals can cause or increase risk of cancer in the number of different ways. Both cobalt and chromium can interfere with cell’s ability 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
Inflitration of Lymphocytes
Stryker submits the stryker Rejuvenate Modular Hip system’s 501(k) to the FDA
Stryker submits the Stryker ABG II Modular-Neck Stem’s 501(k) to the FDA
Stryker begins marketing the Rejuvenate Modular Primary Hip System to doctors and medical facilities
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.
The FDA approves the application, based on a determination that the Stryker Rejuvenate was substantially similar to an existing product.
The FDA approves the application, based on a determination that the Stryker ABG II was substantially similar to an existing product.
Stryker issues an “ Urgent Safety Alert” informing doctors of the potential side effects of using the Rejuvenate system.
April 14, 2008
August 21, 2009
February 2010
July 6, 2012
June 3, 2008
October, 2009
April 2012
THE STRTYKER FAILURE TIMELINE
Recalled Stryker Hip Products?
IMAGINGYour 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 TESTTo check for dangerously high heavy metal (chromium, cobalt & titanium) ion levels that may have become absorbed by the body.
HIP REVISIONHip 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 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 ATTORNEYAs 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.
THANK YOU
Talk with our attorneys to learn more about the Stryker hip recall and your legal rights: (888) 424-5757
www.rosenfeldinjurylawyers.com www.strykerhipfaq.com|
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