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The History of Metal Hip Implants - The Metal on Metal Hip eBook - Part 6

In 1976 medical devices were added to the Food, Drug and Cosmetic Act, placing metal hip implants under FDA regulation. At this time metal-on-metal hip implants were categorized under a Class III or “high risk,” category. Nonetheless, the FDA made the determination to allow regulation of hip implant devices through the 510(k) fast track approval process. Metal-on-metal hip implants were not widely used during the next twenty years, however by the late 1980’s, second-generation metal hip implant designs had been introduced.

Author: Sullo & Sullo Attorneys

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Were Safety Factors Overlooked in the Stryker Rejuvenate and ABG II?

Although Stryker, a Michigan-based corporation issued an Urgent Field Safety Notification to surgeons and hospitals acknowledging the potential dangers of the Stryker Rejuvenate and ABGII hip implants this past April, many believe that crucial safety factors may have been overlooked in the marketing of the device.

Author: Sullo & Sullo Attorneys

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Potential for Fretting and Corrosion in Stryker Rejuvenate and ABG II Lead to Recall

A recent medical study by Carlson, et al (recently published in Volume 27, Issue 7 of the Journal of Arthroplasty) found that modular hip devices such as the Stryker ABGII and the Rejuvenate have a strong potential for corrosion damage at the head-neck junction. The study tested 78 of the implants which were recovered following revision surgery and evaluated them for fretting and corrosion of the metal parts.

Author: Sullo & Sullo Attorneys

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The History of Metal Hip Implants - The Metal on Metal Hip eBook - Part 6

Were Safety Factors Overlooked in the Stryker Rejuvenate and ABG II?

Potential for Fretting and Corrosion in Stryker Rejuvenate and ABG II Lead to Recall

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