BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APR HOODED PROTRUSION ENHANCED INSERT 28MM/57MM

    MDR report key: 49960 · Received November 20, 1996

    Report

    Report Number
    2935620-1996-00011
    Event Type
    Injury
    Date Received
    November 20, 1996
    Date of Event
    August 1, 1996
    Report Date
    November 19, 1996
    Manufacturer
    INTERMEDICS ORTHOPEDICS, INC.
    Product Code
    KWB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY-LINER DISASSOCIATED FROM SHELL. UNDETERMINED WHAT HAPPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APR HOODED PROTRUSION ENHANCED INSERT 28MM/57MM Implant HIP IMPLANT PROSTHESIS KWB INTERMEDICS ORTHOPEDICS, INC. NA 34457

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death| R 4311-00-057