BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK CEMENTED STD FEMUR SIZE 4 LEFT - NARROW

    MDR report key: 4418685 · Received January 8, 2015

    Report

    Report Number
    3005180920-2014-00199
    Event Type
    Injury
    Date Received
    January 8, 2015
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    JWH
    PMA / PMN Number
    K122232
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: GMK PRIMARY CEMENTED STANDARD FEMUR NARROW SIZE 4 LEFT: REF. 02.07.2014L / LOT 132832 ((B)(4) DEVICES PRODUCED AND ALL 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. GMK PRIMARY STD FIXED TIBIAL INSERT # 4-10 MM (K090988): REF. 02.07.0410SF / LOT 130212 ((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. GMK PRIMARY CEMENTED FIXED TIBIA SIZE 4 LEFT (K090988): REF. 02.07.1204L / LOT 132061 ((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
    19000 GMK CEMENTED STD FEMUR SIZE 4 LEFT - NARROW CEMENTED STD FEMUR JWH MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1