Catalog Number 254500718 |
Device Problem
Break (1069)
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Patient Problem
No Information (3190)
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Event Date 11/19/2015 |
Event Type
malfunction
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Manufacturer Narrative
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This complaint is under investigation.Depuy will notify the fda of the results of the 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.Udi# (b)(4).
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Event Description
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A large piece of the attune trial has broken off.This case has been reported by the loan kit technician during loan kit inspection.
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Manufacturer Narrative
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The device associated with this report was not returned.Follow up communication for product return was unsuccessful.(b)(4) was performed by commercialized product development on the attune femoral trial family and concluded there are no design improvements, protective measures or information for safety that would definitely reduce the risks associated with these complaints without potentially increasing/adding other risks.No further work required.Continue to monitor via (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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Manufacturer Narrative
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The investigation has been reopened because the product has been received.Depuy will notify the fda of the results of the investigation once it has been completed.
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Manufacturer Narrative
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Examination of the returned device confirms the reported event of trial breakage.With the provided information, a definitive root cause is unknown.(b)(4) was performed by commercialized product development on the attune femoral trial family and concluded there are no design improvements, protective measures or information for safety that would definitely reduce the risks associated with these complaints without potentially increasing/adding other risks.No further work required.Continue to monitor via (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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