Catalog Number 254400520 |
Device Problem
Component Missing (2306)
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Patient Problem
No Information (3190)
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Event Date 12/04/2015 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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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Event Description
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The femoral guide bushing is missing.
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Manufacturer Narrative
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Additional narrative: 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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Examination of the returned device confirms the reported event of bushing disassociation.The trend of complaints related to the disassociation of a number of these bushings, in correctly manufactured parts, has led to the initiation of corrective and preventative action.The root cause is attributed to product design.(b)(4) is currently underway to investigate this issue.Post market surveillance is per (b)(4).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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Search Alerts/Recalls
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