Catalog Number UNK HIP |
Device Problem
Expiration Date Error (2528)
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Patient Problem
Unspecified Infection (1930)
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Event Date 12/02/2022 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint #: (b)(4).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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Event Description
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It was told that the patient had an expired implant implanted in her, and she is now possibly infected.Not because of the expired implant but because the lady is sick.Doi: (b)(6) 2022.Dor: (b)(6) 2022.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 product/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: a manufacturing record evaluation (mre) was not possible, because the required lot code was not provided.
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Search Alerts/Recalls
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