The request was made in what MassDevice described as a “purported” federal class-action lawsuit filed over the Rejuvenate device. Florida resident, Bernard Owen, received the Rejuvenate in July 2011 and wants the court to recognize a class of plaintiffs. Owen also wants Stryker to cover the monitoring costs for tracking of these patients’ issues with their Rejuvenate implants. According to court documents, Owen is not seeking damages related to the case, said MassDevice.
Stryker recalled its Rejuvenate implants in July 2012 and, this year, advised patients implanted with the Rejuvenate hip device to speak to their surgeons about checking the implant for problems, according to court documents, said MassDevice. The documents also cite a “risk of fretting and corrosion at the modular neck junction.”
“This action for medical monitoring seeks to recover the quantifiable costs of periodic medical examinations necessary to detect the onset of physical harm, but does not seek a damage award attributable to the increased risk of injury caused by the implantation of the defective Rejuvenate system,” according to the lawsuit. “Plaintiff requests that the court exercise its equitable powers to create and supervise a fund for the purpose of monitoring the condition of plaintiff and class members because such monitoring is reasonably necessary,” the lawsuit continued, according to MassDevice.
Earlier this month we wrote that lawsuits in New Jersey involving injuries caused by the Stryker Rejuvenate and ABG II Modular Neck and Hip Stems hip implant components had been consolidated before one Circuit Court judge.
Stryker recalled its Rejuvenate and ABG II hip implant component parts in July of last year after it was determined the modular neck junction part was prone to fretting and corrosion. These defects caused recipients of these devices to suffer severe pain, inflammation, and other injuries that required them to undergo revision or replacement surgeries to alleviate the problems caused by the defects.
Even though the recalled components are not entirely similar to a full metal-on-metal hip implant—the medical device option that has plagued tens of thousands of recipients around the world—Stryker advised, in the months following the recall, that patients who have been fitted with the recalled devices undergo regular screenings to determine if they are suffering from elevated metallic ion levels. This risk may be present in recipients who have not experienced the defect that prompted the recall last year. Elevated metallic ion levels are a hallmark complication caused by metal-on-metal hip implants and could cause recipients to suffer tissue and organ damage.
Stryker warned that some recipients of their recalled component parts have reported suffering from elevated metallic ion levels and has also retained a third-party claims operation to help recipients pay for out-of-pocket expenses caused by its defective and recalled hip implant component parts. Recipients of defective Rejuvenate and ABG II components have reported suffering pain, inflammation, pseudotumors, necrosis of the tissue, bone damage, and limited mobility.