Catalog Number 254500975 |
Device Problem
Break (1069)
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Patient Problem
No Information (3190)
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Event Date 07/20/2015 |
Event Type
malfunction
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Event Description
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The plastic articulating surface broke during trialing.The insert trial broke into two pieces.
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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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).
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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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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.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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This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.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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The complaint consisted of (1) 254500975 attune conv fb ps tb trl sz5, lot number bfa0llb.Examination of the returned device confirms the reported event of trial damage.Cracking on both articulating surfaces initiating around the post was identified.The trial was returned in one piece.A complaints review was completed in february 2014 and in june 2014 for all attune trial instruments, following (b)(4), inclusive of the attune femoral trials, articulation surface trials, and the patella trials.Findings of the complaints review prompted dfmea updates where applicable.These updates were captured in (b)(4), for the femoral trials; and (b)(4) for the tibial trials.The root cause is attributed to user technique and/or misuse.The damage suggests the trial was pryed or otherwise inappropriately removed during trialing.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.
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Search Alerts/Recalls
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