BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY CEMENTED FIXED FEMORAL COMPONENT

    MDR report key: 4195550 · Received September 12, 2014

    Report

    Report Number
    3005180920-2014-00121
    Event Type
    Injury
    Date Received
    September 12, 2014
    Date of Event
    August 11, 2014
    Report Date
    September 12, 2014
    Product Code
    JWH
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: GMK PRIMARY CEMENTED FIXED FEMUR SIZE 2 LEFT: REF. 02.07.2002L / LOT 092291 ((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 CEMENTED FIXED TIBIAL TRAY SIZE 2 LEFT: REF. 02.07.1202L / LOT 104524 ((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 UC FIXED TIBIAL INSERT SIZE 2, 17 MM: REF. 02.07.0217FUC / LOT 092939 ((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, THERE ARE NO EVIDENCES 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
    565437 GMK PRIMARY CEMENTED FIXED FEMORAL COMPONENT CEMENTED FIXED FEMUR STD SIZE 2 LEFT JWH

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention