Catalog Number UNK KNEE TIBIAL INSERT |
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 01/01/2022 |
Event Type
Injury
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Event Description
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It was reported that in (b)(6) 2019, the patient underwent the initial surgery with an attune product.After surgery, on unknown date, the suspect of infection was found.A removal surgery of the implant will be performed on (b)(6) 2022.Details are unknown.No further information is available.
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Manufacturer Narrative
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Product complaint # (b)(4).The primary surgery date was performed on (b)(6) 2019.The removal surgery was done on (b)(6) 2022.Cement molds and beads with vancomycin were placed in this time.We got this info from a sales rep on dec.2, 2022.The device catalog number is unknown; therefore, udi is unavailable.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 medwatch, a follow-up medwatch 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 worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.(b)(6) - (b)(6) 2022. the primary surgery date was performed on (b)(6), 2019.The removal surgery was done on (b)(6), 2022.Cement molds and beads with vancomycin were placed in this time.We got this info from a sales rep on (b)(6), 2022.D4: the device catalog number is unknown; therefore, udi is unavailable.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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