BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY PS CEMENTED FEMUR #4 NARROW RIGHT

    MDR report key: 3870185 · Received May 28, 2014

    Report

    Report Number
    3005180920-2014-00063
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    April 29, 2014
    Report Date
    May 28, 2014
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    JWH
    PMA / PMN Number
    K122232
    Adverse Event
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    NO IMPLANTS REMOVED. ON THE BASIS OF THE DATA COLLECTED, WE HAVE NO EVIDENCES THAT THE PROBLEM IS DEVICE RELATED BUT IT IS LIKELY RELATED TO PATIENT CONDITIONS THAT REQUIRED THE IMPLANTATION OF A RESURFACING PATELLA.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314237 GMK PRIMARY PS CEMENTED FEMUR #4 NARROW RIGHT KNEE PS CEMENTED FEMORAL COMPONENTS JWH MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention