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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