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Stryker Rejuvenate Hip Implant: A Comprehensive Analysis
Litigations filed by over five percent of 20,000 consumers, who received Stryker Rejuvenate hip implants seeking product liability, have raised serious questions on the efficacy and safety of these medical devices. Hundreds of cases of premature failure, metal toxicity, revision surgery, pain, and peripheral tissue damage exemplify the inherent defects and design shortcomings of Stryker Rejuvenate hip implant that was once promoted as more mobile and enduring. The 2012 Stryker Rejuvenate recall has emboldened critics to demand scrapping of the 510k “fast track” FDA approval, through which these hip implants were approved without being tested.
Stryker Rejuvenate Hip Implant: The Design Defect
Contrary to the single femoral component in traditional hip systems, Stryker Rejuvenate hip implant features a chromium-cobalt stem fitted into a titanium neck. Though helpful in customizing the length according to the hip size and ensure more mobility, the design has inherent flaws. Both metallic parts rub against each other, causing corrosion, fretting, loosening, and increased risk of metal toxicity. Fast wearing away causes erosion of the metal that leads to premature device failure.
At least 60 Stryker Rejuvenate hip implant failure complaints were recorded on the MedWatch adverse reporting system in the last six months of the product in the market prior to its 2012 recall.
Stryker Rejuvenate Hip Implant: Injuries and Defects
- Premature failure
- Sudden device break down and dislocation
- Fretting and corrosion causing break down, pain, and inflammation
- Metal poisoning and hypersensitivity
- Bone necrosis and hip tissue death
- Erosion leading loosening and mobility problems
- Enhanced blood cobalt and chromium levels
- Metal toxicity leading to nervous system and cardiovascular side effects
- Osteolysis or bone loss and fractures
Stryker Rejuvenate Hip Implant: Recall and Warnings
Stryker recalled its Rejuvenate hip implants in July 2012 mentioning that “potential fretting and/or corrosion at or about the modular-neck junction, which may result in adverse local tissue reactions manifesting with pain and/or swelling.” The recall came a month after a similar market withdrawal of these devices was announced in Canada. However, it was the increasing number of device failure and metallosis reports that forced the manufacture to declare the recall.
According to FDA reports, the federal regulator twice warned Stryker in 2007 after its team found harmful bacteria at plants where hip implants had been manufactured. In 2009, the American Academy of Orthopedic Surgeons advised against using Stryker hip implant because of squeaking problems associated with them. In 2010, a group of scholars highlighted a 10-time higher risk of increased blood-cobalt level because of metal particles released by metal-on-metal hip implants.
Stryker and 20 other manufacturers were directed by the FDA in 2011 to undertake safety assessments of their hip implant devices.
Stryker Rejuvenate Hip Implant Lawsuit
In December 2013, Stryker settled four Rejuvenate hip implant lawsuits pending for trial in New Jersey. There are over 600 Stryker hip implant lawsuits awaiting trial in the state. Another 462 (Dec 2013 figures) federal litigations involving Stryker Rejuvenate hip implants are centralized at a Minnesota district court. Media reports and financial disclosures by Stryker suggest that the manufacturer is expecting to pay close to $1 billion to settle all hip implant lawsuits filed against it.
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