Stryker Rejuvenate and ABG II Hip Implants Recalled
In June 2012, Stryker Corporation recalled hip implants, Rejuvenate Modular and ABG II modular-neck hip stems, due to fretting and/or corrosion in the implant which may lead to an adverse local tissue reaction, as well as possible pain and/or swelling, in or around the hip. Plaintiffs allege that there are defects and failures of the Stryker Rejuvenate and ABG II artificial hip implants.
Stryker issued an “Urgent Safety Alert”
This follows Stryker’s “Urgent Safety Alert” issued in April 2012 to surgeons regarding the two hip replacement systems. The alert listed “excessive metal debris and/or ion generation” as one of the safety risks to patients. According to Stryker’s Safety Alert, the following problems can result:
- Metallosis (release of metal ions into the tissue and blood stream),
- Necrosis (premature tissue death),
- Osteolysis (bone dissolution),
- inflammatory tissue damage,
- loosening of the implant,
- painful and complicated revision surgeries,
- painful and complex removal surgeries.
Lawsuits charge that the Rejuvenate and ABG II devices are defective because the modular neck is prone to fretting, degradation, and fracture. Injured Plaintiffs allege that Stryker knew or should have known that the Rejuvenate and AGB II hip systems were not safe for patients, yet continued to market and sell the products.
Stryker’s Neck and Stem components
Stryker marketed the Rejuvenate and ABG II systems as the next generation and latest evolution in hip replacements. Typically, artificial hip implants contain a one-piece neck and stem and a cup. Stryker’s Rejuvenate and ABG II systems included multiple neck and stem components at the surgeon’s choice. The ABG II system contained eight right stems, eight left stems, ten modular necks purported to give greater stability and minimal bone stress. The Rejuvenate hip, with six stems and sixteen necks, was marketed to active, younger patients as longer-lasting devices that offered a better range of motion.
Stryker began selling the Rejuvenate hip system in 2009 and the ABG II hip system in 2010. Stryker conducted little to no clinical testing on the safety and effectiveness of either set of devices in hip replacement patients before placing the Rejuvenate and ABG II hip systems on the market.
Chromium, Cobalt and Titanium metals
Physicians and health regulators exposed the dangers to patients from the release of tiny metallic particles by, and the widespread failures of, all-metal (also called metal-on-metal) hip implants. There is no metal ball that rubs against a metal socket, therefore, Stryker’s Rejuvenate and ABG II modular-neck hip stem systems are not actually called metal-on-metal devices. However, the Stryker Rejuvenate and ABG II necks are made of chromium and cobalt, the stems are coated with titanium, they contain a metal-on-metal junction and it is possible to release metallic debris into nearby tissue and the blood stream.
Consolidation of the Litigation
On January 24, 2013, the New Jersey Supreme Court designated all Stryker lawsuits involving recalled ABG II and Rejuvenate hip replacement implants to be consolidated into one multicounty litigation (MCL) before Honorable Brian R. Martinotti who will preside over all pending and future cases in Bergen County Superior Court. Multicounty (MCL) litigation is similar to multidistrict litigation (MDL) in that all the cases are consolidated into one state court, rather than federal court. Each claimant has an individual case and will be heard on in its own individual merits regarding damages and liability. The MCL streamlines the litigation allowing for common procedures regarding service of process, discovery and trial.
Free Medical Legal Consultation
If you or a loved one has received a hip implant, please call for your free medical legal consultation at 1-800-814-4540. There are statutes of limitation in each state, so call or fill out the contact form now to preserve your rights.