BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY TOTAL KNEE SYSTEM

    MDR report key: 23349013 · Received October 21, 2025

    Report

    Report Number
    3005180920-2025-00989
    Event Type
    Injury
    Date Received
    October 21, 2025
    Date of Event
    September 23, 2025
    Report Date
    October 21, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030820212
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 25 SEPTEMBER 2025. GMK-PRIMARY 02.07.2004L FEMORAL COMPONENT CEMENTED STD SIZE 4 / LEFT (K090988) LOT 2203157: 18 ITEMS MANUFACTURED AND RELEASED ON 18-MAY-2022. EXPIRATION DATE: 26-APR-2027. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 17 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-PRIMARY 02.07.1205L TIBIAL TRAY FIX CEMENTED S.5L (K090988) LOT 2200584: 30 ITEMS MANUFACTURED AND RELEASED ON 25-MAY-2022. EXPIRATION DATE: 11-MAY-2027. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 30 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-PRIMARY 02.07.0512FUC TIBIAL INSERT U.C. FIX S.5 / 12 MM (K090988) LOT 1811654: 25 ITEMS MANUFACTURED AND RELEASED ON 21-MAY-2019. EXPIRATION DATE: 07-MAY-2024. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 16 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CONCLUSIONS: INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.

    Description of Event or Problem · 0

    ABOUT 2 YEARS AND 10 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO INFECTION AND THE PATHOGEN IS UNKNOWN. ALL COMPONENTS REVISED TO GMK-REVISION SYSTEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2354823 GMK PRIMARY TOTAL KNEE SYSTEM FEMORAL COMPONENT CEMENTED STD SIZE 4 / LEFT JWH MEDACTA INTERNATIONAL SA 02.07.2004L 2203157 07630030820212

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention