BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUR UNI US POL TIB 8MM LG R M

    MDR report key: 296551 · Received September 14, 2000

    Report

    Report Number
    9610726-2000-00070
    Event Type
    Injury
    Date Received
    September 14, 2000
    Date of Event
    June 16, 2000
    Report Date
    September 14, 2000
    Manufacturer
    STRYKER HOWMEDICA OSTEONICS
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REVISION HAS BEEN REPORTED DUE TO PT PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUR UNI US POL TIB 8MM LG R M IMPLANT JWH STRYKER HOWMEDICA OSTEONICS NA LB51

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention