BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK REVISION TOTAL KNEE SYSTEM

    MDR report key: 22949880 · Received September 3, 2025

    Report

    Report Number
    3005180920-2025-00810
    Event Type
    Injury
    Date Received
    September 3, 2025
    Date of Event
    August 6, 2025
    Report Date
    September 3, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030817410
    PMA / PMN Number
    K103170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEWS PERFORMED ON 08 AUGUST 2025: GMK-REVISION 02.07.0317SCF FIXED TIBIAL INSERT SEMICONSTRAINED S.3 / 17 MM (K103170) LOT 2200918: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-MAR-2022. EXPIRATION DATE: 2027-02-28. 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. SCP17 TINBN COATED SC PEG - 17MM (K210010) LOT 2315191: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-SEP-2023. EXPIRATION DATE: 2028-08-21. 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 DOWNSIZED THE LINER, WHICH IS A COMMON PRACTICE TO RESTORE THE JOINT STIFFNESS. 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 KNEE SURGERY ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT HAD ANTERIOR PAIN AND INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS WITH REVISION COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2025, THE PATIENT HAD STIFFNESS AND LACK OF RANGE OF MOTION AND THE CAUSE IS UNKNOWN. THE SURGEON DOWNSIZED THE POLY TO GIVE THE PATIENT MORE RANGE OF MOTION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1334936 GMK REVISION TOTAL KNEE SYSTEM FIXED TIBIAL INSERT SEMICONSTRAINED S.3 / 17 MM JWH MEDACTA INTERNATIONAL SA 02.07.0317SCF 2200918 07630030817410

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention