BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CMK 2

    MDR report key: 3021146 · Received March 26, 2013

    Report

    Report Number
    1020279-2013-00178
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 2013
    Manufacturer
    SMITH&NEPHEW, INC.
    Product Code
    JDG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO IMPLANT BREAKAGE. THE STEM WAS 16 YEARS IN SITU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123390 CMK 2 CMK 2 STEM SIZE 3S3 JDG SMITH&NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R PART NO:UNK -LINER ¿ 28MM 12 X SIZE 5 LOT NO:UNK| PART NO:UNK -HEAD ¿ D.11 6455-001 5° 43¿ S LOT:UNK