DEPUY ORTHOPAEDICS, INC.1818910 GLOBAL ADVANTAGE PC STEM 12MM; SHOULDER HUMERAL STEM/EPIPHYSIS
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Catalog Number 113712050 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Fracture, Arm (2351)
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Event Date 02/25/2014 |
Event Type
Injury
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Event Description
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During surgery, when patient's arm was externally rotated, the humeral shaft cracked.
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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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If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The device associated with this report was not returned.Review of the device history records did not reveal any and evidence of product contribution.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.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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