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 08/24/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Initial report.Customer has indicated that the product has been discarded, therefore will not be returned to zimmer biomet for investigation.Medical product: oxf uni tib tray sz d rm pma, catalog #:154725, lot #: 734830.Medical product: oxf anat brg rt lg size 4 pma, catalog #:159583, lot #: 169240.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00372, 3002806535-2021-00374.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Discarded.
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Event Description
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It was reported that a patient underwent an initial right knee arthroplasty on (b)(6) 2016.Subsequently, a revision procedure due to pain was performed on (b)(6) 2021.Attempts have been made but no further information has been provided at this time.
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Manufacturer Narrative
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(b)(4).Complaint summary: as the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.In addition, we have not been provided with any supporting documentation which could provide additional information.The source of pain cannot be determined through the radiographs, as only ap radiographs provided, no ml view so a full assessment of size, position and alignment cannot be done.A review of the manufacturing history records confirms no abnormalities or deviations reported, (b)(6) and (b)(6) were issued for item (b)(6) and (b)(6) was issued for item (b)(6).A review of the complaint database over the last 3 years has found (b)(4) complaints reported with the item (b)(6), (b)(4) complaints reported with the item (b)(6) and (b)(4) complaints reported with the item (b)(6) (including the initiating complaint).Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Capa: no corrective or preventive action required at this time.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00372-1.3002806535-2021-00374-1.If any further information is found which would change or alter any conclusions or information, a supplemental will be submitted 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 (b)(6), 2016.Subsequently, a revision procedure due to pain was performed on (b)(6), 2021.Attempts have been made but no further information has been provided at this time.
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Search Alerts/Recalls
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