Model Number N/A |
Device Problem
Positioning Failure (1158)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/11/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Catalog#: 010000860 g7 neutral e1 liner 36mm h lot#: 3743856 catalog#: 010000860 g7 neutral e1 liner 36mm h lot#: 6572975.Report source: foreign : (b)(6).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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-04744, 0001825034-2019-04745.
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Event Description
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It was reported that the liner would not engage in the shell.Two liners were attemped.Shell was replaced and third liner fit into place with no problem noted.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.D4: udi#: (b)(4).The event was confirmed with product received.Visual inspection for the shell found the locking groove to be free of damage.The rim and inner radius of the shell are scratched.The 3 screw hole plugs of the shell are still intact.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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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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