BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK REVISION TOTAL KNEE SYSTEM

    MDR report key: 23153122 · Received September 26, 2025

    Report

    Report Number
    3005180920-2025-00952
    Event Type
    Injury
    Date Received
    September 26, 2025
    Date of Event
    September 4, 2025
    Report Date
    September 26, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    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 SEPTEMBER 2025: GMK-REVISION 02.07.0314SCF FIXED TIBIAL INSERT SEMICONSTRAINED S.3 / 14 MM (K103170) LOT 2346243: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-FEB-2024. EXPIRATION DATE: 31-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. ADDITIONAL DEVICES INVOLVED, BATCH REVIEW PERFORMED ON 17 SEPTEMBER 2025: GMK-REVISION 02.07.4683R TINBN COATED REVISION TIBIAL TRAY SIZE 3 R (K210010) LOT 2247575: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-SEP-2023. EXPIRATION DATE: 21-AUG-2028. 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 02.07.4403R TINBN COATED FEMUR REVISION PS SIZE 3 R (K210010) LOT 2242167: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-JUN-2023. EXPIRATION DATE: 29-JUN-2028. 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. CONCLUSION: 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 HAD PRIMARY SURGERY USING COMPETITOR PRODUCTS BEFORE THE FIRST REVISION. ON (B)(6) 2024, MEDACTA HARDWARE WAS IMPLANTED (GMK-REVISION). ON (B)(6) 2025, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. LINER WAS REVISED. PRESENTLY, ON (B)(6) 2025, THE PATIENT HAD A SECOND REVISION SURGERY DUE TO INSTABILITY AND THE CAUSE UNKNOWN. THE SURGEON REVISED THE INSERT, TRAY, AND FEMUR GMK-REVISION TO GMK-HINGE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310314 GMK REVISION TOTAL KNEE SYSTEM TIBIAL INSERT SC FIXED 14MM, SIZE 3 JWH MEDACTA INTERNATIONAL SA 02.07.0314SCF 2346243

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention