Catalog Number 00801803201 |
Device Problem
Corroded (1131)
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Patient Problem
Pain (1994)
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Event Date 11/06/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-03360.D10: cat #: 00771100900 / femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 9 standard offset / lot#: 62042675 the device will not be returned for analysis; 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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It was reported a surgeon underwent a hip revision due to pain and corrosion.It was reported that no further information is available.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Proposed component code: mechanical (g04)- head.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The complaint cannot be confirmed.Dhr was reviewed and no discrepancies related to the reported event were found.A definitive root cause is unable to 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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