BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK REVISION TOTAL KNEE SYSTEM

    MDR report key: 24078376 · Received January 15, 2026

    Report

    Report Number
    3005180920-2026-00041
    Event Type
    Injury
    Date Received
    January 15, 2026
    Date of Event
    January 9, 2026
    Report Date
    January 15, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030816932
    PMA / PMN Number
    K103170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 13 JANUARY 2026: GMK-REVISION 02.07.0220SCF FIXED TIBIAL INSERT SEMICONSTRAINED S.2 / 20 MM (K103170) LOT 2317384: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-SEP-2023. EXPIRATION DATE: 2028-08-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-REVISION 02.07.0220SCF FIXED TIBIAL INSERT SEMICONSTRAINED S.2 / 20 MM (K103170) LOT 2118827: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-FEB-2022. EXPIRATION DATE: 2027-JAN-31. 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. ROOT CAUSE: 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

    THE PATIENT UNDERWENT AN INITIAL KNEE REPLACEMENT OF UNKNOWN DETAILS, INCLUDING IMPLANT TYPE AND HOSPITAL. ON (B)(6) 2025, THE SPACER WAS REMOVED AND MEDACTA REVISION IMPLANTS WERE IMPLANTED (REASON UNKNOWN). DUE TO PERSISTENT INFECTION, A FIRST POLY INSERT EXCHANGE SURGERY WAS PERFORMED ON 2(B)(6) 2025 (02.07.0220SCF, LOT 2317384), FOLLOWED BY A SECOND EXCHANGE ON (B)(6) 2026 (LOT 2118827) FOR THE SAME REASON. A NEW INSERT OF THE SAME SIZE WAS IMPLANTED. NO IMPLANT DEFECTS, LOOSENING, OR SIZING ISSUES WERE IDENTIFIED. INFECTION WITH SUSPECTED BIOFILM ON THE LINER. THE PATIENT HAS SEVERE COMORBIDITIES, INCLUDING BMI 44.1, WITH POTENTIAL RISK OF AMPUTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145797 GMK REVISION TOTAL KNEE SYSTEM FIXED TIBIAL INSERT SEMICONSTRAINED S.2 / 20 MM JWH MEDACTA INTERNATIONAL SA 02.07.0220SCF 2317384 07630030816932

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Unknown Required Intervention