BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK REVISION TOTAL KNEE SYSTEM

    MDR report key: 21618336 · Received March 17, 2025

    Report

    Report Number
    3005180920-2025-00197
    Event Type
    Injury
    Date Received
    March 17, 2025
    Date of Event
    February 24, 2025
    Report Date
    March 17, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030816598
    PMA / PMN Number
    K103170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 03 MARCH 2025: LOT 2200912: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-APR-2022. EXPIRATION DATE: 2027-03-31. 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. ADDITIONAL IMPLANTS REVISED; BATCH REVIEW PERFORMED ON 03 MARCH 2025: GMK-REVISION 02.07.0682R REVISION TIBIAL TRAY SIZE 2 RIGHT (K123721) LOT 2215010: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-OCT-2022. EXPIRATION DATE: 2027-10-27. 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 02.07.2403R FEMUR REVISION PS CEMENTED S.3R (K102437) LOT 2217576: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-DEC-2022. EXPIRATION DATE: 2027-NOV-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE 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

    THE PATIENT HAD KNEE INSTABILITY AND THE CAUSE IS UNKNOWN. AT ABOUT 9 MONTHS POST MEDACTA PRIMARY, THE SURGEON REVISED ALL THE COMPONENTS IMPLANTING A GMK HINGE SYSTEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1185594 GMK REVISION TOTAL KNEE SYSTEM TIBIAL INSERT SC FIXED 12MM, SIZE 2 JWH MEDACTA INTERNATIONAL SA 02.07.0212SCF 2200912 07630030816598

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention