Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Pain (1994)
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Event Date 10/31/2022 |
Event Type
Injury
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Event Description
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It was reported that the patient underwent revision due to pain, approximately nine (9) years three (3) months after initial surgery.Total knee conversion was performed during the revision.Due diligence is in progress for this event; to date no further information has been provided.
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Manufacturer Narrative
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(b)(4).D-10 oxf twin-peg cmntd fem md pma item#161469 lot#2920019.Oxf anat brg rt md size 3 pma item#159575 lot#2944793.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2022-00470, 3002806535-2022-00473.
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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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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Devices are used for treatment.Radiographs were provided but were of poor quality and unclear dates therefore of no value to this investigation.The medical records provided were reviewed stating the patient is overweight but contain no further information that would enhance this investigation.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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Search Alerts/Recalls
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