Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problem
Insufficient Information (4580)
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Event Date 04/04/2024 |
Event Type
Injury
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Event Description
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It was reported that the patient underwent an acetabular revision procedure due to unknown reasons.There is no additional information available at the time of this report.
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Manufacturer Narrative
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(b)(4).The device will not be returned for analysis as it was discarded; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
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Event Description
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There is no update, to the prior event description provided.
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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.Part and lot identification are necessary for review of device history records, neither were provided for all the devices medical records were not provided.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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Search Alerts/Recalls
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