Catalog Number 121715500 |
Device Problems
Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
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Patient Problems
Pain (1994); No Information (3190)
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Event Date 05/21/2014 |
Event Type
Injury
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Event Description
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Manufacturing date request received regarding pinnacle/corail hip implant revision.Revision confirmed.Date of revision not known, reason for revision not known.
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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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Manufacturer Narrative
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The devices associated with this report were not returned.A complaint database search finds no other related incidents against the provided product and lot combinations.Requests for additional investigational inputs were made in accordance with wi-7915 appendix a.No additional information was obtained.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the inability to identify root cause, the need for corrective action was not indicated.Depuy considers the investigation closed.Should 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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(b)(4).Manufacturing date request received regarding pinnacle/corail hip implant revision.Revision confirmed.Date of revision not known, reason for revision not known.The devices associated with this report were not returned.A complaint database search finds no other related incidents against the provided product and lot combinations.Requests for additional investigational inputs were made in accordance with wi-7915 appendix a.No additional information was obtained.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the inability to identify root cause, the need for corrective action was not indicated.Depuy considers the investigation closed.Should 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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Event Description
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Formal claim received.Revision due to discomfort, pain and raised metal ion levels.Notes report some symptoms of instability, slightly reduced movement and minimal leg length discrepancy.
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Manufacturer Narrative
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No device associated with this report was received for examination.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.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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Search Alerts/Recalls
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