Model Number N/A |
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 05/01/2023 |
Event Type
Injury
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Event Description
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It was reported that patient underwent a knee revision surgery due to unknown reason.Approximately four (4) years ten (10) months from initial surgery.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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(b)(4).D10 - oxf twin-peg cmntd fem sm pma item#161468 lot#: 124440; oxf anat brg lt sm size 5 pma item#: 159542 lot#: 825790.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2023-00151; 3002806535-2023-00154.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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Manufacturer Narrative
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(b)(4).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.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Device are used for treatment.Radiographs were provided and reviewed by a radiologist.No significant findings noted given the images provided.With the available information, a definitive root cause cannot 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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