Center for Devices and Radiological Health, chrome poisoning, Cobalt chrome, Cobalt poisoning, Diana Zuckerman, Federal Food Drug and Cosmetic Act, Food & Drug Administration, Hip recall, Hip Replacement, hip replacement failure, hip revision, Institute of Medicine, Margaret Hamburg, Medical device, Metal on metal hip, New England Journal of Medicine, Total Hip Replacement
Corin FDA Approvals
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Corin 510K Biolox FDA Approval K103120.pdf
Corin BIOLOX delta Modular Femoral Heads K103120-1.pdf
Cormet Cementless Resurfacing Femoral Head K092198.pdf
Trinity Acetabular System K103518.pdf
Corin Metafix Hip Stem K082525.pdf
38 records meeting your search criteria returned – Applicant: Corin
Technorati Tags: Corin Profit, Metal on Metal Hips, Ceramic on Metal Hips, Hip Replacement
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- Report: IOM review of the FDA 510(k) process due Friday (earlsview.com)
- 510(k) reforms: FDA downplays the impact of the IOM study on the eve of its release (earlsview.com)
- Barry Meier – Study Faults Approval Process for Medical Devices (earlsview.com)
- Regulatory Reform Series #5 – FDA Medical Device Regulation: Impact on American Patients, Innovation and Jobs (earlsview.com)
- Flawed Medical Device Approval Process Needs Public Comments, Says The FDA (medicalnewstoday.com)
Howard Sadwin said:
What happens when the metal has friction with ceramic? What affect do these particles have one me,you or anybody if they enter our blood or other bodily parts?
Well, I figure it is a little like rubbing metal on a stone – the metal gets sharper as metal fragments are rubbed off and the stone gets worn away producing dust and grit.
So using my farm-boy logic it seems than you end up with a mix of metal fragments, grit, and synovial fluid – effectively a grinding paste.
And I would imagine that the metal then gets into the tissue, the cobalt dissolves, and you get raised cobalt ions in the blood. The cobalt ions also kill off the bone cells and tissue. The chrome tends to lodge more in the tissues – giving the grey messy look they find – cobalt salts tend to be blue if in great enough concentrations.
That was my point with the analysis of the data on the new ceramic on metal device DePuy have just released – the data shows that cobalt levels go up…
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