Stryker Rejuvenate Recall – Ward Black Law
Personal injury firm Ward Black Law is currently investigating Stryker Rejuvenate recall cases. If you have been implanted with the Stryker Rejuvenate or ABG II Modular-Neck Hip Stem systems and suffered serious side effects including metallosis, dislocation or loosening of the implant, bone fracture or revision surgery, you may be entitled to monetary damages. Contact Ward Black Law today. We are standing by to answer your questions, provide a no-obligation case review and discuss your potential Stryker Rejuvenate recall lawsuit.
Believed to offer more durability, stability and diminished bone stress, metal-on-metal hip implants were initially touted as a breakthrough in the field of orthopedics. They were, however, plagued with problems almost at the outset, culminating in nationwide controversy and thousands of lawsuits against their manufacturers.
In stepped Stryker Orthopaedics, offering an appealing alternative to the all-metal hips. Instead of the one piece, monoblock design of traditional metal hips, Stryker’s Rejuvenate and ABG II systems featured a number of separate, interchangeable components: a femoral stem, a metal neck, a ball and an acetabular cup.
These hips were meant for younger, active individuals. The innovative, modular systems were supposed to provide a more anatomically accurate, customized and comfortable fit that allowed for greater stability, range of motion and long-lasting benefits. Moreover, the devices were marketed as safer options than other implants because the components were cushioned with polyethylene, a plastic-like substance that would prevent the wear-and-tear so characteristic of other devices. There were such high hopes for the Stryker hip systems that they were implanted in more than 20,000 patients.
Stryker Rejuvenate Side Effects
But the Stryker hips proved disappointing. Even though the devices didn’t have a metal-on-metal ball and socket design, the numerous moving parts, coated with titanium, molybdenum, zirconium and iron, were still susceptible to corrosion and fretting, the shedding of microscopic metal particles into the tissue, bones and bloodstream.
In April 2012, Stryker issued an “Urgent Safety Alert” to orthopedic surgeons and hospital risk managers, warning of potential Stryker Rejuvenate side effects. According to the report, contact between metal ions and surrounding cells can result in an Adverse Local Tissue Reaction (ALTR), which can lead to the following:
- metallosis, or metal poisoning
- intense and chronic pain
- limited mobility or difficulty walking and sitting
- urinary irregularities
- tinnitus (ringing in the ears), vertigo or deafness
- optic nerve atrophy
- peripheral neuropathy
- soft tissue damage or necrosis
- nerve and muscle damage
- dissolution of the bone (osteolysis), bone fracture or bone death
- DNA changes and chromosomal aberrations
- loosening or dislocation of the implant
- revision surgery – painful, risky and costly
Stryker advised patients implanted with their hip systems to undergo medical evaluations, including X-rays, MRIs and blood tests, to check for dangerously high metal ion levels in the blood.
Stryker Rejuvenate Recall
The Stryker Rejuvenate and ABG II Modular-Neck Hip Stem were approved by the FDA in June 2008 through the 510(k) fast-track clearance system. Under the 510(k), a drug or medical device can be approved for public use without undergoing pre-market clinical trials if it is “substantially similar” to a product already on the market.
Because Stryker was able to bypass human testing, the hazards of their devices were not evident until much later post-market testing was conducted.
Despite the associated health risks, Stryker did not issue an official voluntary recall of the Rejuvenate and ABG II Modular-Neck Hip Stem systems until July 6, 2012, after receiving more than 60 reports of adverse health events, including claims of metal toxicity and revision surgery. It has stopped production of these products and halted sales. It has also offered some compensation for injured patients, including coverage for testing and removal of failed hips but nothing for long-term medical treatment, lost wages, pain or disability.
But the action came too little too late for some implant patients. Many of the thousands of people who received the hip devices have filed lawsuits against Stryker for the damages they’ve suffered.
If you’ve experienced Stryker Rejuvenate side effects, you may be entitled to compensation. Contact Ward Black Law today to get answers to your questions and discuss your potential Stryker Rejuvenate recall lawsuit. You can reach us by phone: 336-333-2244 or toll-free at 1-877-256-1214 or by email.