Catalog Number UNK HIP ACETABULAR CUP |
Device Problem
Difficult to Insert (1316)
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Patient Problem
No Code Available (3191)
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Event Date 11/05/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint #: (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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This is the fourth hole eliminator they have had problems with since the first on (b)(6).The difference from the others is that this one had the "normale" sound when the apex hole eli.Was screwed in.It didn't stop as the others, and the surgeon tried to turn it out again, but it wasnt possible.They are beginning to feel uncertain about the usage of pinnacle 100 cup and the apex hole, so it is important that the surgeon and the hospital soon get some feedback about this.
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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 completed as the lot number was not known.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 completed as the lot number was not known.
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Search Alerts/Recalls
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