Model Number N/A |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
Joint Dislocation (2374)
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Event Date 04/09/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Initial report.The product has not been retuned to zimmer biomet for investigation.Medical product: oxf anat brg rt md size 5 pma, catalog #: 159577, lot #: 2358861.Medical product: oxf uni tib tray sz c rm pma, catalog #: 154723, lot #: 058170.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00174.3002806535-2021-00176.The investigation is in process.Once the investigation has been completed, 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 (b)(6) 2014.Subsequently, a revision procedure due to bearing dislocation was performed on (b)(6) 2021.
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Manufacturer Narrative
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(b)(4).This final report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00174-1, 3002806535-2021-00176-1.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 x-rays or any supporting documentation which could provide additional information.A review of the manufacturing history records confirms no abnormalities or deviations reported.A review of the complaint database over the last 3 years has found (b)(4) complaints reported with the item159577, (b)(4) complaints reported with the item 161469 and (b)(4)complaints reported with the item 154723.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.
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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) 2014.Subsequently, a revision procedure due to bearing dislocation was performed on (b)(6) 2021.
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Search Alerts/Recalls
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