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Model Number N/A |
Device Problems
Loss of or Failure to Bond (1068); Migration (4003)
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Patient Problem
Failure of Implant (1924)
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Event Date 08/02/2022 |
Event Type
Injury
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Event Description
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It was reported that patient underwent a hip revision approximately 2.5 months post implantation due to a trochanteric avulsion fracture and loss of fixation with vertical migration of the acetabular cup.The stem remained intact and all other components were revised.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).Concomitant medical products: 00787101360 ¿ femoral stem ¿ 65192918; 00877502802 ¿ biolox femoral head ¿ 3085081.Report source: australia.Customer has indicated that the product will not be returned 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 - 01949, 0001825034 - 2022 - 01950, 0001825034 - 2022 - 01952 and 0001825034 - 2022 - 01953.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: issue is loss of cup fixation, now vertical, hinging on superior screws.Also troch avulsion fracture, denies falls/stumbles, not much pain in hip.No observation of periacetabular or pelvic fracture.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot 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 event information to report at this time.
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Search Alerts/Recalls
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