Catalog Number 221750041 |
Device Problems
Break (1069); Difficult to Remove (1528)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/02/2018 |
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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Corail pinnacle - thr; surgeon: (b)(6) health (b)(6) 2018.Total hip replacement.While impacting the pinnacle cup was implant into the acetabulum, the impaction strike plate sheered off.The cup had already been impacted so was then able to be unscrewed from the implant.Action taken: handle removed from set up.Cup had already been impacted satisfactorily.The case then proceeded as usual with no other incident.Surgery not delayed.No ae to patient.Female patient initials s.F., aged (b)(6) years.
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Manufacturer Narrative
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Product complaint # pc-(b)(4).Investigation summary examination of the returned instrument confirmed the complaint.Depuy considers the investigation closed at this time.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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Search Alerts/Recalls
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