BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SULZER MEDICA

    MDR report key: 317272 · Received February 14, 2001

    Report

    Report Number
    MW1021136
    Event Type
    Injury
    Date Received
    February 14, 2001
    Date of Event
    January 23, 2001
    Report Date
    February 10, 2001
    Manufacturer
    SULZER MEDICA SULZER ORTHOPEDICS, INC.
    Product Code
    KWB
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT EXPERIENCED LOOSENING OF ACETABULAR SHELL, (INITIAL SURGERY GREATER THAN 2 MO PREVIOUS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5745 SULZER MEDICA ACETABULAR SHELL KWB SULZER MEDICA SULZER ORTHOPEDICS, INC. ACETABULAR SHELL 1436066

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention