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SmokerX

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SmokerX

Re: farmer6 post# 18402

Monday, 08/27/2018 7:14:16 PM

Monday, August 27, 2018 7:14:16 PM

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https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-orgs/documents/document/ucm595561.pdf

Looks like that's an FDA update for this one.
TLDR: Dr. finds sterile pack stuck to implant. Picks it off and implants it. Triggers FDA inspection. FDA slaps Zimmer around for sterility issues and bagging procedures. Causes inventory issues.

" Necessitates minor medical intervention" in your Risk Management Procedure This assigned severity level does not include the potent
ial severity outcomes of serious injury or death which
can occur as a result of infection. ".

Or bone infection causing osteo myelitis for that matter.

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