BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 4 LEFT

    MDR report key: 6800101 · Received August 17, 2017

    Report

    Report Number
    3005180920-2017-00448
    Event Type
    Injury
    Date Received
    August 17, 2017
    Date of Event
    July 18, 2017
    Report Date
    August 17, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825835
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEWS PERFORMED ON 17 AUGUST 2017. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE INFECTION IS CONFIRMED AS PSEUDOMONAS. THE SURGEON REVISED ALL MEDACTA COMPONENTS AND IMPLANTED NEW MEDACTA PRODUCT WITH ANTIBIOTIC BEADS. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580583 GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 4 LEFT FEMORAL COMPONENT CEMENTED JWH MEDACTA INTERNATIONAL SA 165039 07630030825835

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention