Catalog Number 254500527 |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Information (3190)
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Event Date 03/06/2015 |
Event Type
malfunction
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Event Description
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One of the bal seal retaining lugs has snapped off.Returned from a hospital.No other information available.This case has been reported by the loan kit technician during loan kit inspection.The instrument had further been assessed by depuy engineering.No further information can be obtained as the case was not reported by the customer.
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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 investigation remains closed, as the added information does not change the outcome of the investigation.
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Manufacturer Narrative
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Examination of the returned device confirms the reported event of trial break.The larger post of the trial has fractured and was not returned for evaluation.A complaints review was completed in february 2014 and in june 2014 for all attune trial instruments, following 25,000 and 50,000 surgeries, inclusive of the attune femoral trials, articulation surface trials, and the patella trials.Findings of the complaints review prompted dfmea updates where applicable.The root cause is attributed to user technique and/or misuse.The damage suggests the trial was pryed or otherwise inappropriately removed during trialing.Based on the root cause of suspected misuse, corrective action is not needed.Monitor subsequent reports via sep-419.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.
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Manufacturer Narrative
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Examination of the returned device confirms the reported event of trial break.The larger post of the trial has fractured and was not returned for evaluation.A complaints review was completed in february 2014 and in june 2014 for all attune trial instruments, following 25,000 and 50,000 surgeries, inclusive of the attune femoral trials, articulation surface trials, and the patella trials.Findings of the complaints review prompted dfmea updates where applicable.The root cause is attributed to user technique and/or misuse.The damage suggests the trial was pryed or otherwise inappropriately removed during trialing.Based on the root cause of suspected misuse, corrective action is not needed.Monitor subsequent reports via sep-419.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.
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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.
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Search Alerts/Recalls
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