Catalog Number 154909002 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Pain (1994); Rash (2033)
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Event Date 01/11/2024 |
Event Type
Injury
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Event Description
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It was reported that the patient is positive for nickel allergy and is symptomatic to include itching, rashes, and pain.All components were removed successfully without patient harm or delay and a metal sensitive knee revision was performed utilizing components from a different manufacturer.His initial knee revision was performed on the date listed, however a tibial side revision was also performed on (b)(6) 2023 due to pain.A der was submitted at that time.It was later, when his pain persisted that the metal allergy test was performed and his allergy was confirmed.Doi: (b)(6) 2022.Dor: (b)(6) 2024.Affected side: right.
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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.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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