Model Number N/A |
Device Problems
Difficult to Remove (1528); Separation Failure (2547)
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Patient Problems
Reaction (2414); No Code Available (3191)
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Event Date 01/08/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).An investigation of the reported event is in progress.Once the investigation is completed, a supplemental med watch 3500a will be submitted.Concomitant medical devices: m2a-magnum mod hd sz 44mm item# 157444 lot# 592350; medical device:m2a-magnum 42-50mm tpr insrt-3 item#139254 lot#394350; medical device: us 257850 lot # 336940.
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Event Description
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It was reported that during a hip revision procedure, surgeon did not have appropriate tool to remove components and the revision was unable to be completed.Revision will take place at a later date.Attempts have been made and all available information has been obtained.No additional patient consequences were reported.No components were removed during this procedure.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Reported event was confirmed by additional follow up information which confirmed that the removal tool was not available.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.Root cause was unable to 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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