Model Number N/A |
Device Problem
Separation Failure (2547)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/01/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical devices: part: 110010241, lot: 6819544.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-04356.
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Event Description
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It was reported during an initial right tha, the cup cold-welded to the inserter.Attempts have been made and no further information has been provided.
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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.Reported event was unable to be confirmed.Device history record (dhr) review was unable to be performed as the item and lot number of the device involved in the event is unknown.Root cause could not be determined as the necessary information to adequately investigate the reported event was not provided.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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