Model Number N/A |
Device Problems
Device Dislodged or Dislocated (2923); Insufficient Information (3190)
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Patient Problems
Joint Dislocation (2374); Insufficient Information (4580)
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Event Date 02/22/2023 |
Event Type
Injury
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Manufacturer Narrative
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Cmp#:(b)(4).Report source australia.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, follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 00693, 0001825034 - 2023 - 00694, 0001825034 - 2023 - 00695.
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Event Description
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It was reported that patient underwent a left hip revision after an unknown amount of time post implantation due to unknown reasons.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.D10: 010000703 ¿ g7 shell ¿ 7268284.51-114090 ¿ taperloc stem ¿ 3925856.650-0662 ¿ delta ceramic head ¿ 3096082.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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It was reported that patient underwent a left hip revision approximately 4 months post implantation due to recurring dislocations.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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No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record 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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