Model Number N/A |
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problem
No Information (3190)
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Event Date 12/08/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Initial report.Unique identifier (udi) number: (b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation due to their hospital policy.Once the investigation has been completed, a supplemental mdr will be submitted.Concomitant medical products: medical product: oxf twin-peg cmntd fem md pma, catalog: 161469, lot: 858740.Medical product: oxf anat brg rt md size 6 pma, catalog:159578, lot: 592020.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 knee arthroplasty on (b)(6) 2020.Subsequently, a revision procedure due to tibial subsidence was performed on (b)(6) 2020.
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Manufacturer Narrative
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(b)(4).This report to be voided.On jan 08, 2021, we identified that (b)(4) is duplicate of (b)(4).(b)(4) is to be made not a complaint, therefore, this report is to be voided.The reported event in respect of (b)(4) is reported under 3002806535-2020-00548 and 3002806535-2020-00548-1.
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Event Description
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It was reported that a patient underwent an initial knee arthroplasty on (b)(6), 2020.Subsequently, a revision procedure due to tibial subsidence was performed on (b)(6) 2020.
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Search Alerts/Recalls
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