BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY FEMUR STD CEMENTED SIZE 4 L

    MDR report key: 12265697 · Received August 3, 2021

    Report

    Report Number
    3005180920-2021-00671
    Event Type
    Injury
    Date Received
    August 3, 2021
    Date of Event
    July 23, 2021
    Report Date
    August 3, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030820212
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 28 JULY 2021: LOT 1811521: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-APR-2019. EXPIRATION DATE: 2024-03-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. OTHER DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 28 JULY 2021: GMK-PRIMARY 02.07.0410MUC TIBIAL INSERT UC MOBILE SIZE 4 / 10 MM (NOT REGISTERED IN US) LOT 1904282: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-AUG-2019. EXPIRATION DATE: 2024-07-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-PRIMARY 02.07.1003L TIBIAL TRAY MOBILE CEMENTED SIZE 3 L (NOT REGISTERED IN US) LOT 1903548: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-SEP-2019. EXPIRATION DATE: 2024-09-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT BROKE HIS MEDIAL COLLATERAL LIGAMENTS (CAUSE IS UNKNOWN) THEREFORE THE IMPLANTED PROSTEHSIS WAS NOT STABLE ANYMORE. 1 YEAR AND 7 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON DECIDED TO CHANGE THE PROSTHESIS TO A GMK HINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1166968 GMK-PRIMARY FEMUR STD CEMENTED SIZE 4 L CEMENTED FEMORAL COMPONENET JWH MEDACTA INTERNATIONAL SA 02.07.2004L 1811521 07630030820212

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention