RECALL OF STRYKER REJUVENATE AND ABG II HIP IMPLANTS
On July 6, 2012, Stryker Orthopedics announced that it was voluntarily
recalling its Rejuvenate and ABG II modular-neck hip stems and stopping
global production of these devices. This was done in response to mounting
evidence that these products are prone to fretting and corrosion at the
metal modular neck junctions, resulting in the breakdown and release of
toxic metal debris into the soft tissues surrounding the hip, which causes
pain and/or swelling at the local joint site. In addition, these toxic
metal particles may also enter the bloodstream.
WHAT ARE THE STRYKER REJUVENATE AND ABG II HIP IMPLANTS?
Unlike other metal on metal hip implants which have been the subject of
recalls and litigation, such as the Zimmer Durom Cup and the DePuy ASR™
and ASR™ XL hip implant systems, the Stryker Rejuvenate hip implant
system does not involve a metal on metal ball and cup design. Instead,
the Stryker Rejuvenate is made with a modular femoral neck. This is a
different design than the traditional hip implant devices. Traditional
hip implant devices have two components: a femoral stem with a ball on
the end, and a cup that is placed in the acetabulum of the pelvis. The
Stryker Rejuvenate has four parts: a femoral stem, a metal neck, a ball,
and a cup. Stryker touted the advantages of this modular design as providing
greater options to the implanting surgeon. Because there are number of
different metal neck parts of slightly different lengths and angles the
surgeon can choose from, the surgeon has greater options in terms of the
angle and length of the implant.
Unfortunately, the problem with this design is at the joints between the
modular components. The Stryker hip implant necks are made of cobalt and
chromium, and the stems are coated with titanium. Because the modular
components are made of metal, there is a risk of fretting from the movement
in the metal joints and subsequent corrosion of the metal neck either
at the joint with the femoral stem or the joint where the neck segment
is inserted into the ball. When these metal junctions undergo friction
during periods of activity, microscopic metal particles can shear away
from the implant, lodging into the nearby tissue and/or entering into
WHAT ARE THE ADVERSE EFFECTS OF THE STRYKER REJUVENATE AND ABG II HIP IMPLANTS?
Excessive metal debris can enter the body as a result of corrosion leading
to extreme inflammation and swelling, pseudo tumors, pain and tenderness
at the joint site, a notable decrease in mobility, toxic metal poisoning,
loosening of the hip joint, tissue damage and death, and extreme bone
loss, called osteolysis.
In most cases, patients who have developed any of these problems will require
revision surgery to remove the implant. That is the only way to put an
end to the breakdown of metal debris. This is a very long, complicated
and potentially risky surgery, because it requires removal of not only
the neck component, but also the femoral stem, which was driven down into
the shaft of the femur and cemented into place during the initial hip
WHAT SHOULD YOU DO IF YOU HAVE A STRYKER REJUVENATE OR ABG II HIP IMPLANT?
Those who received a Stryker Rejuvenate or ABG II should see their orthopedic
physician as soon as possible, regardless of whether they are currently
experiencing any symptoms. Stryker has advised patients who received one
of these devices and who are experiencing pain to undergo MRIs, X-rays,
and blood tests to check metal ion levels.
If you underwent a hip replacement in which a Stryker Rejuvenate or ABG
II hip system was used,
contact our office today to discuss your legal rights with one of our defective hip implant attorneys.
At Cannon Dunphy S.C. we can investigate your case and help you determine
the strength of your claim. We are large enough to have the best available
technology and resources available to pursue your case, but small enough
to provide you with the individualized attention that you and your case deserve.