Catalog Number 920010029 |
Device Problems
Break (1069); Detachment Of Device Component (1104); Defective Component (2292)
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Patient Problem
No Information (3190)
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Event Date 12/09/2015 |
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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Defect plastic part to fix the cup to impactor.-the locking catch has a piece broken off, the piece has not been returned.
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Manufacturer Narrative
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Conclusion and justification status: the complaint states defect plastic part to fix the cup to impactor.The investigation confirmed that the locking catch had fractured as reported.Previously a corrective action was identified for this failure mode whereby a design change was implemented and routed on (b)(4) in 2007 in order to strengthen the locking catch.The design verification was completed and routed on (b)(4) and concluded that there are no outstanding actions identified.The complaint shall be closed with a justified conclusion it will be entered into the complaint database and monitored through trend analysis.Depuy still 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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