Model Number N/A |
Device Problems
Unstable (1667); Device Dislodged or Dislocated (2923)
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Patient Problem
Joint Dislocation (2374)
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Event Date 02/26/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical product(s): unknown-unknown head-unknown; unknown-unknown cup-unknown; unknown-unknown stem-unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 00799.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product remains implanted.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 a patient underwent an initial right hip arthroplasty.Subsequently, the patient is being revised due to dislocation, surgery date has yet to be confirmed.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.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product location unknown.
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Event Description
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It was reported the patient underwent a revision procedure due to instability and dislocation.During the procedure, the doctor replaced the poly liner and felt comfortable with the stability of the hip.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.Reported event was confirmed via review of radiographs by a health care professional.Review of the available records identified the following: right total hip arthroplasty with superior dislocation.Part and lot identification are necessary for review of device history records, neither were provided.Root cause of the event could not 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 additional information on reported event.
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Search Alerts/Recalls
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