Model Number N/A |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problems
Failure of Implant (1924); Unspecified Infection (1930); Non-union Bone Fracture (2369)
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Event Type
Injury
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Event Description
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It was reported in a journal article that one patient underwent a two-stage revision approximately 3 years post implantation due to infection, loosening and nonunion of pelvic discontinuity.In the first stage, the patient was left with a girdlestone and implanted with another custom triflange cup in the second stage.The patient completed the study with good clinical outcomes, healed discontinuity, and no further complications.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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(b)(4).Report source: denmark.Product will not be returning to zimmer biomet for the investigation as the product location is unknown.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 - 2022 - 02859.Doi: 10.1302/2633-1462.311.Bj2022-0101.R1.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Part and lot identification are necessary for review of device history records, neither were provided.A definitive root cause cannot be determined for the loosening/bone nonunion.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 event information to report at this time.
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Search Alerts/Recalls
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