BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY TOTAL KNEE SYSTEM

    MDR report key: 23423786 · Received October 30, 2025

    Report

    Report Number
    3005180920-2025-01035
    Event Type
    Injury
    Date Received
    October 30, 2025
    Date of Event
    September 29, 2025
    Report Date
    October 30, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819933
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 09 OCTOBER 2025: GMK-PRIMARY 02.07.1205R TIBIAL TRAY FIX CEMENTED S.5R (K090988) LOT 2207318: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-AUG-2022. EXPIRATION DATE: 26-JUL-2027. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-REVISION 02.07.2406R FEMUR REVISION PS CEMENTED S.6R (K102437) LOT 180123: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-APR-2018. EXPIRATION DATE: 15-APR-2023. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-REVISION 02.07.0514SCF FIXED TIBIAL INSERT SEMICONSTRAINED S.5 / 14 MM (K103170) LOT 1903726: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-JUL-2019. EXPIRATION DATE: 02-JUL-2024. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-REVISION 02.07.0514SCF FIXED TIBIAL INSERT SEMICONSTRAINED S.5 / 14 MM (K103170) LOT 2200931: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-MAR-2022. EXPIRATION DATE: 10-MAR-2027. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING INSTABILITY FOR TWO TIMES AND THE CAUSE IS UNKNOWN. THE FIRST EPISODE OCCURRED ON (B)(6) 2024, AT ABOUT 2 YEARS AFTER THE PRIMARY SURGERY WITH MEDACTA PRODUCTS. THE SURGEON REVISED ONLY THE LINER (FROM 14 MM TO 17 MM). THE SECOND EPISODE OCCURRED ON (B)(6) 2025 THE SURGEON REVISED THE INSERT, TRAY, AND FEMUR FROM GMK-REVISION TO GMK-HINGE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2298044 GMK PRIMARY TOTAL KNEE SYSTEM GMK-REVISION TIBIAL TRAY FIX CEMENTED S.5 JWH MEDACTA INTERNATIONAL SA 02.07.1205R 2207318 07630030819933

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention