Catalog Number UNK-EXTREM |
Device Problem
Break (1069)
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Patient Problem
No Information (3190)
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Event Date 09/12/2016 |
Event Type
Injury
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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.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.Depuy synthes has been informed that the catalog number and lot number is not available.
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Event Description
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Custom elbow implant has broken.
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Manufacturer Narrative
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The device associated with this report was not returned and is presumed yet implanted.Requests for additional investigational inputs were made in accordance with wi-7915 appendix a.No additional information was obtained.Review of the device history records and/or a lot specific complaint database search was not possible as the product and lot code required were not provided.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the inability to determine a root cause, a need for corrective action is not indicated.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.
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Search Alerts/Recalls
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