If you or
a loved one is the recipient of a Stryker ABGII or Stryker Rejuvenate hip
implant device it is very important that you preserve your health, your future
and your right to recovery. Between the time the devices received approval and
hit the market (June 2008 and November, 2009) Stryker received reports of
health and safety risks regarding the Rejuvenate and the ABGII. Surgeons across
the United States submitted reports which voiced concern for the amount of
corrosion and fretting seen in the devices which had been removed from their
patients, with one surgeon stating it looked like “black rust” around the
modular neck junction.
The April 2012 Urgent Safety
Bulletin
In a
safety bulletin sent to surgeons and hospitals in April of 2012, Stryker noted
that excessive metal debris and ion generation were commonly seen in these
Stryker hip implant models. Further, high levels of corrosion and fretting were
resulting from the metal ion generation, leading to early failure of the device
and the necessity of revision surgery. In this safety bulletin Stryker noted
that a certain ph level in some patients caused them to be at a greater risk of
harm. Further, they stated that tapers which were not adequately locked or
sufficiently cleaned could lead to an increase in metal debris generation.
How the Rejuvenate and ABGII
Gained FDA Approval
Both the
Stryker Rejuvenate and the ABGII received FDA approval through a process known
as the 510(k). This process allows medical devices and drugs to skip clinical
trials by asserting they are substantially similar to a device or drug which
has already been approved. Of course the drug or device they are claiming to be
similar to could have gained approval in the same way. In this particular case,
the Wright Profemur was the device the Rejuvenate claimed to be substantially
similar to, and the Profemur has had its share of adverse events among its
recipients as well. This process causes unsuspecting patients to become guinea
pigs as the manufacturer really has no idea whether or not the device or drug
is truly safe. Most of us expect that our surgeons will not implant an unsafe
device into our bodies, and most surgeons expect that an FDA approved device or
drug can be considered safe. Unfortunately this is not always the case, and the
metal-on-metal hip implants have had more than their share of troubles.
Don’t Lose Your Right to File
a Claim against Stryker
It is
believed that over half a million Americans currently have a metal-on-metal hip
implant in their body which is, in some ways, akin to a ticking time bomb. When
the metal ions shear away from the device they become lodged in the surrounding
tissue and cause pain and inflammation or they make their way to the bloodstream
where they can eventually cause metal toxicity. The symptoms of metal toxicity
may lay dormant for as long as several years and if the patient has not
preserved his or her right to recovery—by speaking to an experienced Stryker
hip recall attorney—they could find themselves with damaged health and a
mountain of medical bills following revision surgery.
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