Model Number 159570 |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problem
Failure of Implant (1924)
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Event Date 03/08/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Medical devices: oxf uni tib tray sz b rm pma; item# 154721; lot# 717080.Oxf twin-peg cmntd fem sm pma; item# 161468; lot# 790170.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2023-00101, 3002806535-2023-00102.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 knee revision on their right side for unknown reasons, approximately four (4) years after the initial surgery.No known impact or consequence to the patient.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).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.A review of the device manufacturing records confirmed no abnormalities or deviations.Medical records were not 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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