Model Number N/A |
Device Problem
Device Packaging Compromised (2916)
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Patient Problem
No Information (3190)
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Event Date 01/17/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The complaint device has been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch 3500a will be submitted.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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It was reported that the sales rep noticed inside packaging of implant was cut open; the sterility of the product is compromised.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were updated.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.The femoral component and it's packaging were returned.Form the returned product evaluation it was determined that the box was opened on the wrong side with a clean cut and both the inner and outer tyvek has been cut open.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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