BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK STD CEMENTED FEMUR SIZE 5 RIGHT

    MDR report key: 3832289 · Received May 14, 2014

    Report

    Report Number
    3005180920-2014-00056
    Event Type
    Injury
    Date Received
    May 14, 2014
    Report Date
    July 30, 2015
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    JWH
    PMA / PMN Number
    K090988
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    IN THE INITIAL REPORT THE LAST BATCH REVIEW OF THE PATELLA WAS WRONGLY CUT. HERE IS THE COMPLETE TEXT: GMK PRIMARY RESURFACING PATELLA SIZE 2 REF. 02.07.0034RP/ LOT 091083 ((B)(4) DEVICES PRODUCED AND (b)(4) 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.

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: GMK STAD CEMENTED FEMORAL COMPONENT SIZE 5 RIGHT: REF. 02.07.2005R/LOT 091513 ((B)(4) DEVICES PRODUCED AND ALL 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 UC FIXED TIBIAL INSERT SIZE 5 - 10MM: REF. 02.07.0510FUC/LOT 090933 ((B)(4) DEVICES PRODUCED AND ALL 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 FIXED CEMENTED TIBIAL TRAY SIZE 5 RIGHT: REF. 02.07.1205R/LOT 091460 ((B)(4) DEVICES PRODUCED AND ALL 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 RESURFACING PATELLA SIZE 2: REF. 02.07.0034RP/LOT 091083 ((B)(4) DEVICES PRODUCED AND (B)(4) SOLD WITHOUT ANY OTHER SIMILAR ISSUE REPORTED). ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING, INCLU ... FROM THE DATA COLLECTED, THERE ARE NO EVIDENCES THAT THE INFECTION IS DEVICE RELATED.

    Description of Event or Problem · 1

    REF IMP # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288162 GMK STD CEMENTED FEMUR SIZE 5 RIGHT CEMENTED KNEE FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1