BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APR ACETABULAR INSERT 32MM/49MM

    MDR report key: 65147 · Received January 28, 1997

    Report

    Report Number
    2935620-1997-00002
    Event Type
    Injury
    Date Received
    January 28, 1997
    Date of Event
    November 12, 1996
    Report Date
    January 27, 1997
    Manufacturer
    SULZER ORTHOPEDICS, INC.
    Product Code
    KWB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    NOTICE OF IDE REVISION SURGERY. G860004

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APR ACETABULAR INSERT 32MM/49MM Implant HIP PROSTHESIS IMPLANT LINER KWB SULZER ORTHOPEDICS, INC. NA 7569

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention 4315-00-049, 7200-00-032, 7305-01-135