Catalog Number UNK HIP ACETABULAR CUP |
Device Problem
Difficult to Insert (1316)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Code Available (3191)
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Event Date 10/30/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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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Instead of screwing the hole eliminator tight in the pinnacle cup, it is possible to screw it all the way through the cup.The surgeon has to take care not screwing it to far because there is a chance that you will lose the eliminator behind the cup.This has happened 5 times now with this procedure.The only lot number i have is this one.
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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 which has not been investigated or verified 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.Patient code: removed code for no patient consequence and replaced with no code available (3191) to capture surgery prolonged.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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Event Description
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Additional information was received stating that there was a delay of 3 minutes in order to put in another hole eliminator.
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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 search of the depuy nonconformance (nc) quality system could not be done, as the lot number was unknown.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers, the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot: a search of the depuy nonconformance (nc) quality system could not be done, as the lot number was unknown.
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Search Alerts/Recalls
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