Catalog Number 151820606 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Infection (1930)
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Event Date 04/16/2024 |
Event Type
Injury
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Event Description
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It was reported that patient underwent total knee arthroplasty on (b)(6) 2024.Surgeon presented in clinic with signs of infection.Poly was exchanged, aggressive debridement was performed and new poly was placed.Doi: on (b)(6) 2024, dor: on (b)(6) 2024, affected side: left knee.
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Manufacturer Narrative
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Product complaint (b)(4) 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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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A manufacturing record evaluation was performed for the finished device product description: atune cr lt ms ins sz 6 6 product code: 151820606 lot number: m54k36 and no non-conformances or manufacturing irregularities were identified.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 : a manufacturing record evaluation was performed for the finished device product description: atune cr lt ms ins sz 6 6 product code: 151820606 lot number: m54k36 and no non-conformances or manufacturing irregularities were identified.
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Search Alerts/Recalls
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