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.
5. 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.
CONCERN
OVER 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
Neck
16
(8 right, 8 left)
10 6
16
Neck
Stem
6. 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)
7. 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)
8. 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)
9. 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)
10. 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
11. 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
February 2010
July 6, 2012
June 3, 2008
October, 2009
April 2012
THE STRTYKER FAILURE TIMELINE
12. Recalled Stryker Hip Products?
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
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 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 Stryker hip recall lawyer immediately to protects your rights.
13. 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|