BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE FIXED TIBIAL INSERT RIGHT #4-12 MM

    MDR report key: 4418668 · Received January 8, 2015

    Report

    Report Number
    3005180920-2014-00198
    Event Type
    Injury
    Date Received
    January 8, 2015
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K121416
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: GMK SPHERE FLEX FIXED TIBIAL INSERT SIZE 4 - 12 MM RIGHT: REF. 02.12.0412FR / LOT 143393 ((B)(4) DEVICES PRODUCED AND (B)(4) ALREADY SOLD WITHOUT ANY OTHER SIMILAR ISSUE REPORTED). ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING, INCLUDING WASHING AND STERILIZATION PROCEDURES. FROM THE DATA COLLECTED AND THE INFORMATION RECEIVED, THERE ARE NO EVIDENCES THAT THE INFECTION IS DEVICE RELATED.

    Description of Event or Problem · 1

    REF IMPORTER REPORT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18999 GMK SPHERE FIXED TIBIAL INSERT RIGHT #4-12 MM FIXED KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA

    Patients

    Seq Age Sex Outcome Treatment
    1