Catalog Number 254400525 |
Device Problem
Misassembly by Users (3133)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/14/2018 |
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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Subject id: (b)(6).Clinical ae received for protocol deviation, incorrect jig setup: "external rotation paddles set at 3° left (not right).Noticed at end of bony cuts however, the jig was anatomically aligned and although the patella was tracking well on trial reduction." database indicates event is procedure related.
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Manufacturer Narrative
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Product complaint # : (b)(4).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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