BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY TOTAL KNEE SYSTEM

    MDR report key: 22060632 · Received May 21, 2025

    Report

    Report Number
    3005180920-2025-00463
    Event Type
    Injury
    Date Received
    May 21, 2025
    Date of Event
    April 24, 2025
    Report Date
    May 21, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030816321
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 21 MAY 2025 (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-JULY-2022. EXPIRATION DATE: 2027-07-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICES INVOLVED: GMK-REVISION 02.07.FSC11065 EXTENSION STEM - CEMENTED Ø 11 L 65 (K120790) LOT. 2419562 (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-OCT-2024. EXPIRATION DATE: 2029-10-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. GMK-REVISION 02.07.4681L TINBN COATED REVISION TIBIAL TRAY SIZE 1 LEFT (K210010) LOT. UNKNOWN GMK-PRIMARY UNKNOWN FEMUR IMPLANT. ROOT CAUSE: 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

    REVISION SURGERY DUE TO KNEE INSTABILITY OF THE COLLATERALS. THE SURGEON REVISED ALL SYSTEM WITH A GMK HINGE. PRIMARY SURGERY UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645171 GMK PRIMARY TOTAL KNEE SYSTEM TIBIAL INSERT PS FIXED SIZE 1/20MM JWH MEDACTA INTERNATIONAL SA 02.07.0120PSF 2209252 07630030816321

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention