Catalog Number 121712056 |
Device Problem
Difficult To Position (1467)
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Patient Problem
No Information (3190)
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Event Date 05/22/2017 |
Event Type
Injury
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Manufacturer Narrative
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This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.(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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It was reported that the surgeon was impacting the ceramic liner into a pinnacle duofix cup in the normal fashion; 4 taps to impact, on the fourth tap the liner twisted and shattered.As a result the surgeon had to extract the cup and liner and open a new implant.
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Manufacturer Narrative
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Depuy considers the investigation closed at this time.Should the 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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Manufacturer Narrative
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It was reported that the surgeon was impacting the ceramic liner into a pinnacle duofix cup in the normal fashion; 4 taps to impact, on the fourth tap the liner twisted and shattered.As a result the surgeon had to extract the cup and liner and open a new implant.The reported event has been evaluated and will be monitored.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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Manufacturer Narrative
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It was reported that the surgeon was impacting the ceramic liner into a pinnacle duofix cup in the normal fashion; 4 taps to impact, on the fourth tap the liner twisted and shattered.As a result the surgeon had to extract the cup and liner and open a new implant.The reported event has been evaluated and will be monitored.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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