Catalog Number 151810032 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Pain (1994); Osteolysis (2377); Not Applicable (3189)
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Event Date 01/08/2018 |
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 11 may 2018.Left knee revised to address pain and aseptic tibial base plate loosening.Revising surgeon noted villonodular synovitus consistent with implant loosening.Pathology sent intraoperatively identified no acute infection.Femoral component was well-fixed.Some posterior femoral osteolysis was identified, requiring augmentation of the revised femur.The tibial base plate component was loose and came out by hand.There was no bonding of the cement to the backside of the base plate.The bone cement was well-fixed to the tibia bone.The patella component tracked well and was not revised.(it is noted that the primary attune total knee arthroplasty revised in this complaint was itself a revision of a failed patellofemoral knee arthroplasty.The manufacturer of the patellofemoral knee components has not been provided.If additional information is provided, then this patellofemoral revision event may be reported.).
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Manufacturer Narrative
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(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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