BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE COMPONENT

    MDR report key: 597545 · Received April 28, 2005

    Report

    Report Number
    2249697-2005-00042
    Event Type
    Injury
    Date Received
    April 28, 2005
    Date of Event
    February 26, 2003
    Report Date
    April 1, 2005
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    REPORTED BY THE PATIENT'S LEGAL REPRESENTATIVE THAT ALLEGEDLY, IN 2003 THE PROSTHETIC PARTS FAILED CAUSING KNEE REPLACEMENT REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN KNEE COMPONENT IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention