Catalog Number UNK KNEE TIBIAL TRAY |
Device Problems
Loss of or Failure to Bond (1068); Migration or Expulsion of Device (1395); Migration (4003)
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Patient Problems
Pain (1994); Synovitis (2094); Tissue Damage (2104); Osteolysis (2377); Not Applicable (3189)
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Event Date 08/21/2017 |
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.Right knee revised to address pain and aseptic loosening of the tibia base plate.Revising surgeon identified marked synovitis with metallosis.He also stated that the femur was well-fixed, but the tibia base plate was grossly loose.He also indicated that the tibia prosthesis had subsided posteromedially, and there was osteolysis present beneath both tibia and femur components.Femur, tibia and insert components were all revised to competitor knee products; patella was retained.Pathology specimens sent intra-op confirmed metallosis in the synovium.No product or lot code information provided in records for primary attune total knee, nor the manufacturer of the bone cement used.Doi: (b)(6) 2014; dor: (b)(6) 2017; (right knee).
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Manufacturer Narrative
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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, a follow-up medwatch will be filed as appropriate.
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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.
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Search Alerts/Recalls
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