BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK FIXED PS TIBIAL INSERT SIZE 3 - 14 MM

    MDR report key: 4418667 · Received January 8, 2015

    Report

    Report Number
    3005180920-2014-00197
    Event Type
    Injury
    Date Received
    January 8, 2015
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    JWH
    PMA / PMN Number
    K090988
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: GMK PRIMARY PS FIXED TIBIAL INSERT SIZE 3 - 14 MM: REF. 02.07.0314PSF / LOT 102827 ((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 EVENT 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
    19955 GMK FIXED PS TIBIAL INSERT SIZE 3 - 14 MM PS FIXED KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1