Hip Replacement Recall Legal Help Center
Attorneys Seeking Compensation on behalf of patients affected by the Stryker Hip Replacement Recall
On July 6, 2012 – Stryker announced their decision to voluntarily recall several hip replacement implant models due to problems associated with a neck component call the V40 femoral head. The V40 femoral head is made of chromium and cobalt, when the chromium and cobalt femoral head wears against the titanium hip replacement stems, it sheds metallic debris into the body and can lead to serious complications.
Surgeons first began using hip replacement models affected by this recall in 2010. Models associated with the recall include Exeter, Citation, Meridian, Reliance, Definition, Restoration, Accolade Rejuvenate and ABG 2 systems.
Although Stryker refuses to comment on the actual failure and revision rates of the Rejuvenate and ABG II devices, hundreds of complications involving the implants were received by the Food and Drug Administration (FDA) in 2012. Experts urge anyone who received these implants to consider having their blood tested for cobalt and chromium levels, whether they suffer from symptoms or not.
In an Urgent Field Safety Notice issued immediately before the recall, Stryker warned that post-market data revealed that the Rejuvenate and ABG II had an increased rate in Adverse Local Tissue Reaction (ALTR) – meaning complications arising from inflammation in the tissue in and around the implant.
The notice states several potential hazards:
- Fretting and corrosion in and around the modular neck junction can release excessive metal debris into the surrounding tissue.
- Metal ions in surrounding tissues can result in inflammation leading to an immunological response including metallosis (metal poisoning), necrosis (tissue and bone death) and pain requiring revision surgery.
- Patients with metal sensitivity may have a severe allergic reaction that requires revision surgery.
- Excessive metal debris in the joint space can lead to osteolysis, also known as bone loss, and may require revision surgery.
Studies also suggest that absorbed metal ions can cause neurological and heart problems, as well as damage to the lymph nodes, spleen, liver and kidneys. Cobalt is considered especially toxic.
Experts urge anyone who received these implants to consider having their blood tested for cobalt and chromium levels, whether they suffer from symptoms or not. Cobalt-chromium levels of above 0.3 micrograms per liter (mg/l) or parts per billion (ppb) are considered abnormal and should be monitored for any future complications.
Stryker has hired Broadspire, a third party risk management company, to gather information and process claims related to its recalled hip implants. Broadspire’s job is to verify that claimants actually have the recalled devices and to reimburse out-of-pocket expenses for medical treatment related to Stryker’s recalled implants. There can be a benefit to the uninsured patient seeking reimbursement for medical expenses or gaining approval to have expensive procedures paid for by the company, however, broadspire is only reimbursing for out of pocket medical costs and does not reimburse for emotional distress, disability, suffering or loss of quality of life. In order to receive compensation for these additional damages, patients must file a claim in a civil action before the expiration of the statute of limitations.
Patients affected by the Stryker hip recall should consider that Broadspire works for Stryker and may put their interests ahead of a patient’s. For instance, any medical information gathered may be used in any future lawsuits and can negatively impact a claimant’s case. Claimants wishing to deal with Broadspire, should consult an attorney to protect his or her legal rights to any future litigation against Stryker.
Lawsuits filed against Stryker allege that the company was negligent in failing to warn the public about the high rate of failure. They also accuse the company of making fraudulent claims that the titanium and cobalt chrome neck and stem in the Rejuvenate and ABG II were resistant to fretting and corroding.
The hip recall lawyers of Arentz Law Group are now taking hip recall cases on an individual one-on-one basis. Stryker claims it will cover reasonable and customary costs of monitoring and treatment but, in reality, they have requested that patients submit all of their bills to private health insurance (including Medicare and employer sponsored – ERISA – health insurance plans), offering only to pay the patient’s out-of-pocket co-pays and deductibles. This is not justice for the patient or your health insurance carriers who are in essence paying for Stryker’s mistakes. At Arentz Law, we believe that medical device manufacturers should be held accountable for unsafe products.
In addition to medical costs, legal claims can account for lost wages or loss of earning capacity; effects on patient overall mental and physical well-being; duration and extent of the injuries suffered; mental anguish and pain; as well as any disfigurement or scarring caused by the defective Stryker Rejuvenate and ABG II Modular-Neck Stem hip replacement implants.
Arentz Law Group, along with our partner firms, has recovered more than $1 billion in settlements and verdicts on behalf of injured consumers. Contact an Arentz lawyer at 1-800-305-6000 or fill out the contact form on this page. All hip replacement injury consultations are free and confidential. Time to file a claim is limited so please do not hesitate to contact us!