Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problem
Arthritis (1723)
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Event Date 10/31/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: medical product: oxf uni tib tray sza rm/ll pma catalog #: 154719 lot #: 702940, medical product: oxf anat brg rt sm size 4 pma catalog #: 159569 lot #: 923050.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00888, 3002806535-2019-00889.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.
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Event Description
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It was reported that a patient underwent an initial right knee arthroplasty on unknown date in (b)(6) 2011.Subsequently, a revision procedure was performed due to lateral progression.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Unique identifier (udi) number: (b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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It was reported that a patient underwent an initial right knee arthroplasty on unknown date in (b)(6) 2011.Subsequently, a revision procedure was performed due to lateral progression.
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Search Alerts/Recalls
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