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FDA, Industry Debates 510(k)

06/18/2013
Defective Medical Devices
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The Food and Drug Administration (FDA) held a meeting this week to consider whether the 510(k) approval process for medical devices is keeping the public safe while balancing the need of industry to get innovative products to the market faster and easier. “External stakeholders” were invited and helped set the […]

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Consumers: Report Adverse Events with Metal Hips to FDA

02/26/2013
Articles
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A patient with a metal-on-metal or any hip replacement that causes symptoms or problems requires that the individual become his/her own best advocate. First, make an appointment with an orthopedic surgeon for evaluation which includes not just a physical exam but an examination of fluid around the joint/ soft tissue […]

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Study: Women Suffer More Hip Implant Complications

02/22/2013
Articles
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In one of the largest studies of its kind, researchers have determined that women have a slightly elevated chance of needing a hip revision before a man. Researchers from Kaiser Permanente looked at 35,000 hip surgeries in 46 hospitals within their healthcare system. While men had an average of 1.9 […]

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Gravity of Rejuvenate Defects Finally Acknowledged

01/17/2013
Blog
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Stryker is finally acknowledging that their Rejuvenate and ABG II modular hip product line can cause serious problems in patients – even if they aren’t yet feeling symptoms of metal poisoning or tissue destruction. Since the Rejuvenate product recall on July 4th, Stryker has been telling patients that if you […]

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Posted By: Bud Wilder