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Model Number N/A |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Fall (1848); Necrosis (1971); Joint Dislocation (2374)
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Event Date 11/19/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant products: 010000980 3929945 g7 freedom const e1 lnr 32mm b; 110010261 6952447 g7 osseoti multihole 46mm b; competitor polar femoral component.Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the device was requested, but not returned by the hospital.The investigation is in process.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 - 2021 - 03272.
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Event Description
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It was reported patient underwent right hemiarthroplasty to repair a femoral neck fracture.Subsequently 3 dislocations occurred resulting in conversion to right total hip arthroplasty approximately 3 moths post right hemiarthroplasty.Patient sustained a fall approximately 6 weeks post op that resulted in a dislocation and 2 additional dislocations occurred post reduction.Revision performed approximately 3 months post tha with removal of head/liner, and competitor stem.Surgeon noted necrosis of capsule and well-fixed acetabulum.Attempts have been made and additional information on the reported event is unavailable.
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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 medical records received.Review of the available records identified findings of recurrent dislocations.Patient dislocated multiple times post-op after a previous revision.Necrosis, well-fixed cup, and previous cables were removed, no complications during this revision.The device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined, however, it was noted a competitor stem was used with a zimmer biomet head/liner, and while this is considered off-label use it is unknown if this caused or contributed to the event.If any further information is found which would change or alter any conclusions or information, a supplemental report 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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