The Stryker Rejuvenate system was approved by the FDA in June 2008 and the ABG II system was approved in November 2009. Unlike many hip implant systems, Stryker’s Rejuvenate and ABG II systems include several neck and stem components. The purpose was to provide surgeons with greater flexibility. The rejuvenate system was targeted towards younger patients looking for a system that would provide greater survivorship.
Tellingly, in April 2012, Stryker issued an “urgent safety alert” to surgeons and hospitals alerting them to the side effects associated with these two systems. Namely, the excessive metal ions and metal debris which has plagued metal-on-metal hip implants since their introduction to the market. But also, the corrosive and fretting effect of the neck junction which may lead to “increased metal ion generation in the surrounding joint space.”
The urgent alert comes in the wake of a study published in the Journal of American Academy of Orthopaedic Surgeons in April 2012 warning that corrosion is a reason for failure of modular implants. Specifically, the study found that there is an increased concern for component failure through taper fretting, fatigue fracture and corrosion, all of which can lead to elevated metal ion levels.
On May 28, 2012, the Stryker Rejuvenate system was recalled in Canada so that the instructions for use could be updated. In July 2012, Stryker issued a recall of both the Rejuvenate and ABG II modular neck stems. Reportedly, the FDA obtained more than 60 adverse event reports related to these hip implants. Some of the adverse events related to metal debris and one of them involved the removal of the implant.
Since the recall, the company has advised patients to see their surgeon to have blood levels tested for metal ions and to also undergo X-Rays and MRIs to monitor the hip implants. Some of the common side effects and complications that might arise from having a Stryker Rejuvenate or ABG II metal-on-metal hip implant include:
Metal-on-metal hip implants continue to pose a serious health risk to patients. The FDA recently asked 21 manufacturers to monitor the metal ion levels of patients implanted with metal-on-metal hip devices.
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Once a preliminary evaluation is done on your case, you will receive a packet. The packet contains a contract, questionnaire and authorization. This information is necessary to further evaluate your claim and to obtain your medical records. Obtaining your medical records can take 3o to 60 days. After the medical records are retrieved, an attorney will review your records and a determination will be made on your case.
If your case is accepted, a lawsuit will be filed. Pharmaceutical and medical device cases are frequently grouped together or “consolidated” in one court before one judge. This helps the discovery process proceed more quickly and efficiently. These consolidations are known as “MDLs” or Multi-District Litigation. An MDL is not a class action. Your case will be evaluated, tried and ultimately settled on the merits of your particular case.
If you had a Stryker Rejuvenate hip implanted and have been having problems or required a revision surgery, please contact our law firm. An experienced attorney will provide a free case evaluation and analyze the facts of your case. We handle all cases on a contingency basis, meaning that we don’t get paid unless we win.