BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC MODULAR KNEE SYSTEM CRUCIATE RETAINING TIBIAL TRAY

    MDR report key: 91030 · Received May 15, 1997

    Report

    Report Number
    1219655-1997-00091
    Event Type
    Injury
    Date Received
    May 15, 1997
    Date of Event
    April 10, 1997
    Report Date
    May 15, 1997
    Manufacturer
    JOHNSON & JOHNSON PROFESSIONALS, INC.
    Product Code
    HSH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H6-ONE 86-4115 P.F.C. KNEE POROUS COATED TIBIAL TRAY CONMPONENT WAS RECEIVED IN THE APPLIED RESEARCH LABORATORY FOR NON-DESTRUCTIVE VISUAL EVALUATION. MUCH OF THE TRAY'S POROUS SURFACE WAS COVERED BY FIROUS TISSUE OR DRIED PHYSIOLOGICAL FLUIDS WITH NO EVIDENCE OF BONE CEMENT. THE FINISHED GOODS AND SINTERING RECORDS WERE REVIEWED FOR THE TIBIAL TRAY MFG LOT AND WERE WITHIN SPECIFICATION. NO MATERIAL OR MFG DEFECTS WERE FOUND ON THE TIBIAL TRAY.

    Description of Event or Problem · 1

    REVISION KNEE SURGERY WAS PEFORMED TO REMOVE POROUS TIBIAL TRAY COMPONENT DUE TO LOOSE BEADS AND SUBSEQUENT LOOSENING OF TRAY. NO OTHER DETAILS HAVE BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC MODULAR KNEE SYSTEM CRUCIATE RETAINING TIBIAL TRAY Implant CRUCIATE RETAINING POROUS TIBIAL TRAY COMPONENT HSH JOHNSON & JOHNSON PROFESSIONALS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention