Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 06/18/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, discarded.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 during the revision of the left hip, during cup insertion, the third screw fractured as it was being screwed in.A delay of 10 mins was noted while a portion of the broken screw that was projecting into the cup was burred down to allow proper seating of the liner.A 30mm piece of the screw is still in the patient.Attempts to obtain additional information have been made; however, no more is available.
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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 confirmed by review of pictures.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.
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Search Alerts/Recalls
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