Catalog Number 217863136 |
Device Problems
Dull, Blunt (2407); Appropriate Term/Code Not Available (3191)
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Patient Problem
No Information (3190)
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Event Date 10/09/2017 |
Event Type
malfunction
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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.
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Event Description
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Der states that the patient had an articulating knee spacer in for about two years.Patient had very sclerotic bone in both the proximal tibia and distal femur.When using the tapered tibial reamer, the reamer caught and the hudson adapter stripped and popped off the reamer.Damaged pieces due to the original hudson adapter:
(b)(4) mbt rev cem stem reamer, (b)(4) modified hudson adapter.
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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.
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Manufacturer Narrative
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Examination of the submitted devices confirmed the reported event.Depuy considers the investigation closed.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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