BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK FIXED CEMENTED TIBIAL BASE PLATE RIGHT

    MDR report key: 4425602 · Received January 14, 2015

    Report

    Report Number
    3005180920-2014-00203
    Event Type
    Injury
    Date Received
    January 14, 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 FIXED CEMENTED TIBIAL TRAY SIZE 3 RIGHT: REF. 02.02.1203R / LOT 122302 ((B)(4) DEVICES PRODUCED AND ALL ALREADY SOLD WITHOUT ANY OTHER SIMILAR ISSUE REPORTED. ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECS VALID AT THE TIME OF MFG, INCLUDING WASHING AND STERILIZATION PROCEDURES. GMK PRIMARY UC FIXED TIBIAL INSERT SIZE 3 - 12 MM: REF. 02.07.0312FUC / LOT 121963 ((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 SPECS VALID AT THE TIME OF MFG, INCLUDING WASHING AND STERILIZATION PROCEDURES. GMK PRIMARY STANDARD CEMENTED FEMUR SIZE 3R: REF. 02.07.2003R / LOT 122093 ((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 SPECS VALID AT THE TIME OF MFG, INCLUDING WASHING AND STERILIZATION PROCEDURES. FROM THE DATA COLLECTED AND THE INFO RECEIVED, THERE ARE NO EVIDENCE THAT THE EVENT IS DEVICE RELATED.

    Description of Event or Problem · 1

    IMP REF # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34914 GMK FIXED CEMENTED TIBIAL BASE PLATE RIGHT KNEE TIBIAL BASE PLATE JWH MEDACTA INTERNATIONAL, SA 122302

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK