Stryker Rejuvenate Hip Recall
New York City Defective Medical Device Lawyers
On July 6, 2012, Stryker Orthopaedics issued a recall of its Rejuvenate
and ABG II modular hip implants. This hip implant recall followed a recall
of the defective product in Canada in the spring of 2012. According to
the recall notice posted on the FDA's website, the hip implants have
been recalled because of a fretting and corrosion at the modular neck
junction. This deterioration leads to the deposit of metal ions into the
soft tissue surrounding the hip joint, which results in metallosis, necrosis,
and osteolysis, any of which may result in the need for a revision surgery,
where the hip implant is removed and replaced with another implant.
This recall is the latest in a string of negative information that has
been amassing about
metal-on-metal hip implants. In August of 2010, DePuy Orthopaedics
recalled two if it's metal-on-metal hip implants and several other
metal-on-metal hip implants have been discontinued. Recently, the FDA
convened a panel of experts to evaluate metal-on-metal hip implants. Although
the panel did not recommend an outright recall of all metal-on-metal hip
implants, it did find little reason to use the implants and cautioned
doctors against their use. Although the Rejuvenate and ABG II models do
not have the same design defect as many of the metal-on-metal hip implants,
which are susceptible to excessive wear on the articulated surfaces of
the femoral head and acetabular cup, the developing data indicates that
there is a design defect in modular neck junction of these devices.
Stryker began selling the Rejuvenate and ABG II models in the United States
in 2009. Post-market surveillance of the device disclosed excessive adverse
event reports suggestive of a trend toward an unusually high failure rate.
Patients have complained of pain, swelling, and discomfort in the hip
area. If you are experiencing any of these symptoms, you should contact
your orthopedic surgeon and have your hip implant evaluated. You should
also contact a lawyer knowledgeable about the Stryker Rejuvenate hip implant
recall and the developing litigation.
free, initial case consultation with our firm today.
Contact Sullivan & Brill, LLP for reliable representation.