Model Number N/A |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Patient Involvement (2645)
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Event Date 01/14/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported that the bearings were missing when they were putting the tray together.
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Event Description
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No further event information available at the time of this report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Complaint sample was returned and evaluated against the reported event.Visual inspection notes the product exhibits signs of repeated use with nicks and gouges and has one of two components disassembled/missing.The missing component was not returned.Dhr was reviewed and no discrepancies were found.The root cause is considered to be a previously addressed design issue.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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