BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTER-OP ACETABULAR SHELL

    MDR report key: 314403 · Received January 29, 2001

    Report

    Report Number
    MW1020954
    Event Type
    Malfunction
    Date Received
    January 29, 2001
    Date of Event
    January 1, 2000
    Report Date
    January 29, 2001
    Manufacturer
    SULZER ORTHOPEDICS (DIV. SULZER MEDICA)
    Product Code
    KWB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    LOOSENING OF THE SULZER MEDICA (SULZER ORTHOPEDICS) ACETABULAR SHELL. HAD TO UNDERGO REDO'S OF THEIR TOTAL HIP SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3444 INTER-OP ACETABULAR SHELL PROSTHESIS, JOINT, HIP, ACETABULAR COMPONENT, 53MM FLARE SHE KWB SULZER ORTHOPEDICS (DIV. SULZER MEDICA) * 1415123

    Patients

    Seq Age Sex Outcome Treatment
    1 NA