Model Number N/A |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problem
Pain (1994)
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Event Date 08/09/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).D10 ¿ medical devices: oxf uni tib tray sza rm; item# 154719; lot# 084710.Oxf anat brg rt sm size 4 pma; item# 159569; lot# 845070.Multiple mdr reports were filed for this event, please see associated reports: 3002806535 - 2023 - 00294.3002806535 - 2023 - 00295.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 patient underwent a partial knee arthroplasty and approximately 5 years later a revision surgery was performed due to wear and knee pain.Attempts have been made and no further information has been provided.
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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.Devices are used for treatment.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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