Model Number 1024-54-307 |
Device Problem
Difficult to Insert (1316)
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Patient Problem
Insufficient Information (4580)
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Event Date 04/12/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (b)(4).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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It was reported that during a routine sigma uni knee, it was discovered that the poly insert would not seat appropriately into the metal tibial tray and loosening of the poly insert from metal tibial tray.Surgeon noticed it didn't "sit" like normal and could easily elevate it out of the tray.Opened another and it was better, but not perfect causing him to think that maybe there was something wrong with the metal tray.At this point surgeon decided it was good enough and didn¿t want to make things worse by explanting the entire construct.5 minutes surgical delay.No further patient information available.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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Search Alerts/Recalls
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