BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK REVISION TOTAL KNEE SYSTEM

    MDR report key: 23437043 · Received October 31, 2025

    Report

    Report Number
    3005180920-2025-01064
    Event Type
    Injury
    Date Received
    October 31, 2025
    Date of Event
    October 9, 2025
    Report Date
    October 31, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030816710
    PMA / PMN Number
    K103170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 17 OCTOBER 2025: GMK-REVISION 02.07.0214SCF FIXED TIBIAL INSERT SEMICONSTRAINED S.2 / 14 MM ( K103170) LOT. 2008655: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 SEPT 2020. EXPIRATION DATE: 07 SEPT 2025. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 26 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-REVISION 02.07.SCP14 TINBN COATED SC PEG - 14MM (K210010) LOT. 2341851: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29 JAN 2024. EXPIRATION DATE: 08 JAN 2029. 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. THE SURGEON REVISED LINER HEIGHT, WHICH IS A COMMON PRACTICE TO RESTORE THE JOINT STABILITY. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 0

    AT 1 YEAR AND 1 MONTH AFTER THE PRIMARY SURGERY, THE PATIENT PRESENTED WITH INSTABILITY OF UNKNOWN CAUSE. THE SURGEON UPSIZED BOTH THE INSERT AND THE PEG FROM 14 MM TO 17 MM TO IMPROVE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1907403 GMK REVISION TOTAL KNEE SYSTEM GMK-REVISION FIXED TIBIAL INSERT SEMICONSTRAINED S.2 / 14 MM JWH MEDACTA INTERNATIONAL SA 02.07.0214SCF 2008655 07630030816710

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention