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A new study highlights the risks that patients face as a result of the recalled Stryker Rejuvenate hip replacements, indicating that individuals may face a high rate of complications even after the modular hip implants have failed and been removed.
In a study published last month in the Journal of Arthroplasty, researchers with the Division of Adult Reconstruction and Joint Replacement Surgery at the Hospital for Special Surgery in New York, warn that they found a 13% complication rate associated with Stryker Rejuvenate hip revision surgery.
The Stryker Rejuvenate is a modular hip implant that was recalled in July 2012, after the manufacturer acknowledged that a higher than expected number of patients were experiencing problems with the device, often involving fretting or corrosion at the point where the two metal pieces fit inside each other, often resulting in the need for risky revision surgery to remove the implant.
Unlike traditional hip replacements, which feature a single femoral component, the Stryker Rejuvenate and ABG II implants have a modular stem, where the surgeon is able to adjust the length to match the patient’s anatomy. However, as the metal components rub against each other during normal daily activities, it has been discovered that the design allows microscopic metallic debris to be released into the body, increasing the risk of loosening and failure.
About 20,000 of the hip implants were sold before the recall, and many experts have previously suggested that a growing number of individuals will experience failure and require revision of their Stryker Rejuvenate hip as the devices remain in place.
This latest study looked at short-term outcomes and complications following hip revision surgery, where the implants were removed from patients. The retrospective cohort study involved 92 patients who underwent revision of a Stryker Rejuvenate hip between July 2011 and April 2014, with one year and two year follow-ups.
The findings indicate that 13% of patients who had the implants removed suffered from complications, such as greater trochanteric fractures, dislocations, asceptic loosening and infections. According to the data collected, two-thirds of patients who had revision surgery and suffered complications required additional surgery.
“Patients’ physical function improvements were offset by worsened mental function scores,” the researchers noted. “Patients undergoing revision of Rejuvenate modular neck THA implants should be counseled on modest functional improvements and relative frequency of complications.”
Stryker Rejuvenate Lawsuit Settlements
Since the Stryker Rejuvenate recall, more than 5,000 hip replacement lawsuits have been filed by individuals who experienced complications, and most of those cases have settled.
Last year, a global Stryker Rejuvenate settlement was reached by the manufacturer to resolve all cases where plaintiffs underwent revision surgery on or before November 2, 2014. Under terms of that initial settlement, individuals who qualified received a base payment of $300,000, with several factors that may reduce the base award, including the plaintiff’s age, prior hip revision surgeries and other related health conditions. In addition, individuals who suffered catastrophic injuries are able to pursue additional compensation under the settlement if they meet several eligibility requirements for “enhancements.”
As other individuals continue to experience problems in the future, it is expected that Stryker will continue to face litigation over the Rejuvenate for years, as hip replacement lawyers continue review and file cases for individuals who had the recalled hip implanted and are now experiencing problems that require revision surgery.