Catalog Number 545050501 |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problems
Pain (1994); Not Applicable (3189)
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Event Date 02/20/2018 |
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.
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Event Description
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Reviewed medical records received on 14 may 2018.Records indicate patient, who had a primary attune left total knee replacement, presented with increasing severe left knee pain, requiring the use of a cane, with evidence of aseptic tibial loosening and medial tibial collapse.Revision operative record stated tibial base plate was grossly loose, "able to be elevated simply with an osteotome and removed".There was a significant amount of bone loss medially of the proximal tibia.Stated that the femur component was well-fixed with "some mild bone loss around the edges".Only the tibia base plate and tibia insert were revised.Depuy bone cement was utilized in primary.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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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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Search Alerts/Recalls
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