BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK REVISION TOTAL KNEE SYSTEM

    MDR report key: 21739733 · Received April 1, 2025

    Report

    Report Number
    3005180920-2025-00231
    Event Type
    Injury
    Date Received
    April 1, 2025
    Date of Event
    March 3, 2025
    Report Date
    April 1, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030818578
    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 24-MAR-2025. LOT 2200931: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-MAR-2022. EXPIRATION DATE: 10-MAR-2027. 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

    THE PATIENT HAD A PRIMARY SURGERY ON (B)(6) 2023. SUBSEQUENTLY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN WAS UNKNOWN. ON (B)(6) 2023, THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY. PRESENTLY, ON (B)(6) 2025, THE SURGEON REVISED THE 17MM POLY WITH A 14MM LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1171186 GMK REVISION TOTAL KNEE SYSTEM GMK-REVISION 02.07.0517SCF FIXED TIBIAL INSERT SC SIZE 5/17MM JWH MEDACTA INTERNATIONAL SA 02.07.0517SCF 2200931 07630030818578

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention