BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUR UNI US POL TIB 8MM MD R M

    MDR report key: 277620 · Received May 11, 2000

    Report

    Report Number
    9610726-2000-00029
    Event Type
    Injury
    Date Received
    May 11, 2000
    Date of Event
    April 27, 2000
    Report Date
    May 11, 2000
    Manufacturer
    HOWMEDICA INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY HAS BEEN REPORTED DUE TO LOOSE AND WORN POLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUR UNI US POL TIB 8MM MD R M IMPLANT JWH HOWMEDICA INC. NA LAIB

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention