Catalog Number UNKNOWN |
Device Problems
Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Failure of Implant (1924); Pain (1994); Insufficient Information (4580)
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Event Date 08/28/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).G2-foreign-australia.D10.Item#:unknown; lot#:unknown ;item name: unknown oxford cemented tibia; item#:unknown; lot#:unknown ;item name: unknown oxford articulating surface.H3-other: device evaluation could not be performed as part# and lot# unknown.Also device location is unknown.Multiple mdr reports were filed for this event, please see associated reports: 3002806535 - 2023 - 00317, 3002806535 - 2023 - 00318.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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It was reported that the patient underwent revision surgery due to unknown reasons.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).Upon review of this complaint from an investigation perspective, it is now considered that the oxford femoral component within this complaint does not impact the reported event.Hence this report will be voided.The device involved in the reported event have already been reported.See report number 3002806535-2023-00318.Given the above information, this product will now be considered an associated item.
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Event Description
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Upon review of this complaint from an investigation perspective, it is now considered that the oxford femoral component within this complaint does not impact the reported event.Hence this report will be voided.The device involved in the reported event have already been reported.See report number 3002806535-2023-00318.Given the above information, this product will now be considered an associated item.
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Search Alerts/Recalls
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