Catalog Number 150600004 |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problems
Pain (1994); No Code Available (3191)
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Event Date 09/17/2018 |
Event Type
Injury
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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.Concomitant med products: attune fb tib base sz 4 cem knee tibial tray component; unknown knee femur component; attune ps fb insert sz 6 10mm knee tibial insert component; unknown knee patella component; unknown bone cement.(b)(4) no code available is to address the reported ¿surgical intervention¿.
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Event Description
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The patient was revised to address pain and loosening of the tibia at the cement to implant interface.Cement manufacturer is unknown.Poly and attune tribal base plate were removed and replaced with attune revision tibial baseplate and new poly.Doi: (b)(6) 2014.Dor: (b)(6) 2018.Left knee.
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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.Should additional information be received, the information will be reviewed and the investigation may 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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