Catalog Number 161468 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Insufficient Information (4580)
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Event Date 01/29/2024 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).D10 - associated medical devices: oxf uni tib tray sz b rm pma; item# 154721; lot# 592820.Oxf anat brg rt sm size 3 pma; item# 159568; lot# 218830.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2024-00071.3002806535-2024-00073.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 3500a will be submitted.
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Event Description
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It was reported that the patient underwent a revision surgery approximately seven years post initial implantation due to unknown reasons.Due diligence is in progress for this complaint; to date no additional information or product has been received.
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2024-00071-1.3002806535-2024-00073-1.This follow-up report is being submitted to relay additional and/or corrected information.No products were returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.With the available information, a definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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