New research has shown a connection between the type of corrosion with the Stryker Orthopedics Rejuvenate Modular Hip System (below) and local soft tissue destruction. Previously some Stryker Rejuvenate patients did not have legal recourse because hip replacement attorneys were only accepting metal-on-metal claims. Now that this new report has found a potential link with components in the Stryker Orthopedics Rejuvenate Modular Hip System device, Stryker Rejuvenate claims are being investigated and litigation is underway.
Stryker Rejuvenate & Soft Tissue Destruction
A report in The Journal of Bone and Joint Surgery (May 15, 2013) studied 12 hips in 11 patients who underwent total hip arthroplasty with a modular femoral stem design by Stryker Rejuvenate, consisting of a titanium-molybdenum-zirconium-iron alloy body mated with a modular cobalt-chromium alloy neck. Upon revision surgery, all 11 patients showed local soft tissue destruction with visible corrosion at the femoral neck-body junction. And they also had increased levels of chromium, cobalt and titanium in their blood, which indicates metallosis.
This new research indicates that patients implanted with the recalled Rejuvenate and ABG II Modular-Neck Hip Stems should be evaluated for local tissue reactions (i.e., necrosis in surrounding tissue) and blood testing to ensure their hips are functioning properly and to prevent further complications such as metallosis, even if they are not experiencing any Stryker hip side effects. And it has paved the way for Stryker Hip recall lawsuits.
The Stryker Rejuvenate hip implant is different from other hip replacement devices in the news regarding lawsuits because it is not a metal-on-metal hip replacement device. Instead, the Rejuvenate hip replacement device, which uses a ceramic component, was meant as an alternative to the metal-on-metal devices. It was marketed to younger patients as a modular hip replacement, meaning the components were custom-made to fit patients better, which was supposed to result in longer-lasting hip replacement devices that offered a better range of motion.
Stryker Rejuvenate Hip Implant
Some patients reportedly developed metallosis after having the Stryker Rejuvenate hip device implanted. Although it was initially believed that such a condition was not possiblebecause the Stryker Rejuvenate does not have a metal-on-metal ball and socket designthe Stryker hip device has a metal neck piece that can, under some conditions, rub against a metal stem, causing metallic debris to come loose.
Stryker Rejuvenate Hip Problems
Stryker has responded to concerns about the Rejuvenate failure rate by alleging patients did not properly undergo rehabilitation following surgery, or by blaming doctors' implantation techniques. In a Product Correction Bulletin (04/25/12), Stryker officials noted, "Factors such as diabetes and infection may play a role in potential corrosion of an implant as these conditions may affect the pH of the tissue surrounding the implant."
Metallosis is an adverse tissue reaction to heavy metals in the body. It can cause pain, limited mobility, failure of the hip joint, pseudo-tumors, dissolution of the bone, DNA changes and chromosomal aberrations. Patients who have had their Stryker Rejuvenate hip implant device fail may have undergone revision surgery. Typically, hip implants are expected to last 15 to 20 years. In some cases, the Stryker Rejuvenate hips are failing in less than five years.
In July 2012, Stryker voluntarily recalled its Rejuvenate and ABG II modular-neck stems from the market. The products were recalled due to reports of fretting and corrosion. According to some reports, the FDA received two adverse events linked to the recalled devices, including one in which the device was removed.
Stryker Rejuvenate Recall
On May 28, 2012, Health Canada announced that Stryker Rejuvenate was being recalled so the instructions for use could be updated. The recall affected only Rejuvenate devices sold in Canada and was based on a reported rate of less than one percent for revisions associated with the Rejuvenate.
Since the Stryker Orthopedics Rejuvenate Modular Hip System Recall last July 2012, an increasing number of Stryker hip replacement lawsuits continue to be filed nationwide. The Stryker hip claimants allege complications including Stryker orthopedics metallosis, osteolysis (dissolution of bone) and necrosis in tissue surrounding the implant. As of May 2013, more than 160 Stryker hip recall lawsuits have been filed in a consolidated litigation currently underway in New Jersey's Bergen County Superior Court. Eighty-one claims have already been filed in the New Jersey litigation early in 2013. Plaintiffs in the federally-filed Stryker hip replacement lawsuits petitioned the U.S. Judicial Panel on Multidistrict Litigation (JPML) to establish a consolidated proceeding for those claims in a single federal court.
Stryker Rejuvenate Lawsuit Update
A case management conference has been scheduled for June 18 by Judge Brian R. Martinotti, who is overseeing the New Jersey Stryker hip recall litigation. The lawsuits claim that patients with Stryker Rejuvenate and ABG II hip stem recall are entitled to compensation for lost wages, medical bills, and pain and suffering.
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