Catalog Number 122132048 |
Device Problems
Connection Problem (2900); Positioning Problem (3009)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/13/2018 |
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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Der states that surgeon set the liner into the pinnacle cup and it dropped into position without impaction, he implanted the liner and it would not seat.There was no firm contact and he was able to pluck it out of the cup with his fingers.Opened a second poly and it worked just fine.The reason why the first liner would not seat is not known.Doe: (b)(6) 2018.
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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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Manufacturer Narrative
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Product complaint #: (b)(4).Investigation summary: examination of the returned device has not identified product error regarding the reported event.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: ha1785.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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Search Alerts/Recalls
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