Catalog Number 122128144 |
Device Problem
Misconnection (1399)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
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Event Date 10/12/2016 |
Event Type
Injury
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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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If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).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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Event Description
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Poly would not stay in cup.
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Manufacturer Narrative
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Poly would not stay in cup.Examination of the reported devices was not possible as they were not returned.A search of the complaints databases finds no other reports against the product and lot code combinations since their release to distribution.The investigation can draw no conclusion with the information provided.Based on the inability to determine root cause, the need for corrective action has not been indicated.Depuy considers the investigation closed.Should additional information be received the investigation will be reopened.
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Search Alerts/Recalls
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