Model Number N/A |
Device Problems
Device Packaging Compromised (2916); Packaging Problem (3007)
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Patient Problem
No Patient Involvement (2645)
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Event Date 04/04/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).(b)(6).Reporter had indicated that product will be returned.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001825034-2018-03091.
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Event Description
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It was reported that the sterile package of the device was damaged.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.
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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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Udi: (b)(4).Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned device confirmed that the blisters had protrusion/dents from the implant movement.The sterility however was not compromised.The seal was still intact when products were received for investigation.Device history record (dhr) was reviewed and no discrepancies 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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 03091 - 2.
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Search Alerts/Recalls
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