Catalog Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Arthritis (1723); Insufficient Information (4580)
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Event Date 05/25/2023 |
Event Type
Injury
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Event Description
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It was reported that the patient underwent partial knee arthroplasty.Subsequently, the patient underwent revision surgery due to an 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).D10.Item#:unknown ;lot#:unknown ;item name: unknown oxford tibial component ; item#:unknown ;lot#:unknown ;item name: unknown oxford bearing component ; multiple mdr reports were filed for this event, please see associated reports: 3002806535 - 2023 - 00193.3002806535 - 2023 - 00194.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
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Event Description
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Additional information was received indicating that a revision surgery was needed due to lateral progression of the patient's arthritis.Upon review of this information, it is now considered that the oxford femoral component within this complaint has not caused or contributed to the reported event.Hence this report will be voided.
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Manufacturer Narrative
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Additional information was received indicating that a revision surgery was needed due to lateral progression of the patient's arthritis.Upon review of this information, it is now considered that the oxford femoral component within this complaint has not caused or contributed to the reported event.Hence this report will be voided.
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Search Alerts/Recalls
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