BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERMEDICS

    MDR report key: 91928 · Received May 14, 1997

    Report

    Report Number
    91928
    Event Type
    Injury
    Date Received
    May 14, 1997
    Date of Event
    May 8, 1997
    Report Date
    May 9, 1997
    Manufacturer
    INTERMEDICS ORTHOPEDICS
    Product Code
    HSH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TITANIUM & POLYETHYLENE SYNOVITIS OF RIGHT KNEE FROM FAILED RIGHT TOTAL KNEE FEMORAL COMPONENT FROM MFR'S DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERMEDICS Implant * HSH INTERMEDICS ORTHOPEDICS R TOTAL KNEE 7554-11106-12388-12566

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R