BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUR UNI US POL TIB 8MM LG R M

    MDR report key: 286740 · Received July 21, 2000

    Report

    Report Number
    9610726-2000-00055
    Event Type
    Injury
    Date Received
    July 21, 2000
    Date of Event
    June 22, 2000
    Report Date
    July 20, 2000
    Manufacturer
    STRYKER HOWMEDICA OSTEONICS
    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. PT HAD COMPLAINED ABOUT 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 LALJ

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention