Catalog Number 545050501 |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problem
Insufficient Information (4580)
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Event Date 09/19/2023 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint #(b)(4).Dmf# - 13704.Trade name gentamicin sulphate.Active ingredient(s) gentamicin sulphate.Dosage form - powder.Strength 1.0g active in our cements.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Event Description
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It was reported that there was a loosening of tibial component which led to the revision of primary total knee.The attune tibial tray was loose at cement to implant interface.The cement manufacturer is depuy.Unknown surgical delay.Doi: unknown.Dor: (b)(6) 2023.Affected side: unknown.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.An evaluation of the manufacturing record could not be performed as the required lot number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot the device lot number is unknown, therefore a device history review could not be performed. if the lot/serial number becomes available, the record will be re-assessed.
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Search Alerts/Recalls
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