Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Insufficient Information (4580)
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Event Date 02/22/2023 |
Event Type
Injury
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Event Description
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It was reported that patient underwent an initial uni knee arthroplasty and subsequently a revision surgery was performed due to unknown reason.Due diligence is in progress for this complaint; to date no additional information or product has been received.
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Manufacturer Narrative
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(b)(4).Concomitant medical products: unknown oxford femoral component; item# unknown; lot# unknown; unknown oxford tibial component; item# unknown; lot# unknown.Multiple mdr reports were filed for this event: 3002806535 - 2023 - 00075; 3002806535 - 2023 - 00077.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Device location unknown.
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Event Description
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Upon due diligence of the reported event, it was determined a medwatch report should not have been filed because the complaint is a duplicate of (b)(4).Given this information, this medwatch will be voided.
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Manufacturer Narrative
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(b)(4).Upon due diligence of the reported event, it was determined a medwatch report should not have been filed because the complaint is a duplicate of (b)(4).Given this information, this medwatch will be voided.
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Search Alerts/Recalls
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