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Stryker Hip Recall Alert

 

Issue: Recalled Rejuvenate and ABG II hip implants

Stryker began selling the Rejuvenate hip system in 2009 and the ABG II hip system in 2010. Two years later, Stryker recalled these hip implants. Stryker did not conduct any clinical testing on the safety and effectiveness of the Rejuvenate and ABG II hip systems before selling the devices.

On November 3, 2014, the parties announced a settlement of the litigation valued at over $1 billion.

Stryker Settlement

Under the settlement, Stryker will provide a base payment of $300,000 to patients that received the Rejuvenate or ABG II hip systems. And who underwent revision surgery by November 3, 2014, to remove and replace the devices.

The base award may be adjusted upward depending on individual factors. For example, payments will be increased for extraordinary medical injuries, such as multiple surgeries (re-revisions) or infections and other medical complications suffered as a result of revision surgery.

The deadline for eligible patients to submit their claim for payment under the settlement is March 2, 2015. The first payments under the settlement program are expected to begin in the Summer of 2015 with enhanced payments being projected for disbursement at the end of 2015 and early 2016.

Importantly, the Stryker settlement is not for a fixed sum. In other words, Stryker’s ultimate liability is not capped. It is expected that the total amount of payments under the settlement will far exceed $1 billion dollars.

Recall of Stryker Rejuvenate and ABG II Modular-Neck Hip Implant Systems

Stryker marketed the Rejuvenate and ABG II systems as being the “next generation” and “latest evolution” in their hip replacement product lines. Most artificial hip implants consist of a one-piece neck and stem, and a cup. Stryker’s Rejuvenate and ABG II systems included multiple neck and stem components that the from which the surgeon could choose.

The ABG II system had eight right stems, eight left stems, and ten modular necks, which were supposed to offer greater stability and minimal bone stress. The Rejuvenate hip, with six stems and sixteen necks, was marketed to younger patients who were promised longer-lasting devices that offered a better range of motion.

Physicians and health regulators have focused substantial attention on 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. Stryker’s Rejuvenate and ABG II modular neck hip stem systems are not considered metal-on-metal devices since they do not have a metal ball that rubs against a metal socket. However, because the Stryker Rejuvenate and ABG II necks are made of chromium and cobalt, and the stems are coated with titanium, they do have a metal-on-metal junction and can release metallic debris into nearby tissue and the blood stream.

In April 2012, Stryker issued an “Urgent Safety Alert” to surgeons for 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); and,
  • Pain and loosening of the hip implant requiring revision surgery.

Stryker Hip Recall Lawsuits

In lawsuits filed against Stryker, patients with faulty hip implants charge that the Rejuvenate and ABG II devices are defective because the modular neck is prone to fretting, degradation, and fracture. Further, the lawsuits allege that Stryker knew or should have known that the Rejuvenate and AGB II hip systems were not safe for the patients, yet continued to market and sell the products. The lawsuits by the Stryker hip patients are seeking compensation for pain and suffering, medical expenses including the cost of replacement surgery and lost past and future wages.

Important Notice for Stryker Hip Recall Patients Not Covered Under Settlement

Patients with a Stryker Rejuvenate or ABG II hip systems that fail and require revision surgery after November 3, 2014, are not eligible for this phase of the settlement and retain their rights to pursue claims for compensation against Stryker. If you fall into this category, please contact The Bongiorno Law Firm for a FREE consultation.

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