BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK REVISION TOTAL KNEE SYSTEM

    MDR report key: 23532098 · Received November 12, 2025

    Report

    Report Number
    3005180920-2025-01098
    Event Type
    Injury
    Date Received
    November 12, 2025
    Date of Event
    October 21, 2025
    Report Date
    November 12, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819346
    PMA / PMN Number
    K123721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 28 OCTOBER 2025: GMK-REVISION 02.07.0682L REVISION TIBIAL TRAY SIZE 2 LEFT (K123721) LOT 2009564: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-JAN-2021. EXPIRATION DATE: 20-DEC-2025. 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 02.07.2403L FEMUR REVISION PS CEMENTED S.3L (K102437) LOT 2008812: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-OCT-2020. EXPIRATION DATE: 11-OCT-2025. 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: 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

    ON (B)(6) 2022, THE PATIENT HAD PRIMARY LEFT KNEE SURGERY. ON (B)(6) 2022, THE PATIENT HAD KNEE PAIN. THE SURGEON DECIDED TO REVISE THE PATIENT AND DISCOVERED THAT TIBIA, FEMUR, AND PATELLA WERE LOOSE AND DID NOT BOND WITH THE CEMENT. THE CAUSE OF THIS IS UNKNOWN. THE SURGEON REVISED ALL IMPLANTS. MDR 3005180920-2022-00412. ON (B)(6) 2025, THE PATIENT HAD KNEE PAIN DUE TO LOOSENING OF THE CEMENTED FEMORAL AND TIBIAL COMPONENTS. THE SURGEON REVISED ALL COMPONENTS TO GMK-REVISION AND ADDED CONES FROM A COMPETITOR. THE RESURFACED PATELLA FROM THE FIRST REVISION WAS RETAINED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2033909 GMK REVISION TOTAL KNEE SYSTEM GMK-REVISION REVISION TIBIAL TRAY SIZE 2 LEFT JWH MEDACTA INTERNATIONAL SA 02.07.0682L 2009564 07630030819346

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention