Catalog Number 103545000 |
Device Problem
Misconnection (1399)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Information (3190)
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Event Date 09/21/2017 |
Event Type
malfunction
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Manufacturer Narrative
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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 reported that bipolar poly would not seat correctly inside of outer diameter metal head on both implants and there was movement of 2mm on the lip.
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Manufacturer Narrative
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If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
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Manufacturer Narrative
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Product complaint # = > pc-(b)(4).Investigation summary = > examination of the returned device is unable to determine a root cause for the problems experienced.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.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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Complaint description: it was reported that bipolar poly would not seat correctly inside of outer diameter metal head on both implants and there was movement of 2mm on the lip./ | investigation method: / | investigation summary:.
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Search Alerts/Recalls
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