Catalog Number UNK HIP FEMORAL AUGMENT |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); No Code Available (3191)
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Event Date 08/03/2020 |
Event Type
Injury
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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.(b)(4).
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Event Description
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It was reported that as per surgeon, patient has infected hip.Patient has srom stem and competitor cup.No records of when or where surgery took place.Found this lot number on stem l- b13837.Surgeon placed prostalac in.Doi: unknown, dor: (b)(6) 2020, affected side: unknown.
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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.This report may be based on information prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: h6 (method, conclusion and result codes).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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Search Alerts/Recalls
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