BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOD ENHCD INS 32/55 APR

    MDR report key: 407942 · Received July 30, 2002

    Report

    Report Number
    2935620-2002-00200
    Event Type
    Injury
    Date Received
    July 30, 2002
    Date of Event
    February 19, 2002
    Report Date
    July 10, 2002
    Manufacturer
    SULZER ORTHOPEDICS, INC.
    Product Code
    KWB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED: PT REVISED IN 2002, POLY INSERT WAS FOUND TO BE EXTREMELY WORN. DOCTOR REQUESTS INVESTIGATION OF EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOD ENHCD INS 32/55 APR HIP PROSTHESIS KWB SULZER ORTHOPEDICS, INC. NA 31463

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R