BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY TOTAL KNEE SYSTEM

    MDR report key: 21662619 · Received March 21, 2025

    Report

    Report Number
    3005180920-2025-00201
    Event Type
    Injury
    Date Received
    March 21, 2025
    Date of Event
    February 24, 2025
    Report Date
    March 21, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819896
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 3 MARCH 2025: LOT 2248135: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21/03/2023. EXPIRATION DATE: 08/03/2028. 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 DEVICE INVOLVED: GMK-SPHERIKA 02.12.KA03R FEMORAL COMPONENT SPHERIKA CEMENTED S3R (K211004) LOT 2339464: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08/11/2023 EXPIRATION DATE: 22/10/2028. 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. 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

    THE PATIENT CAME IN REPORTING PAIN DUE TO A METAL SENSITIVITY AND THE CAUSE IS UNKNOWN. ABOUT 9 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED ALL COMPONENTS TO ANTIALLERGIC COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337051 GMK PRIMARY TOTAL KNEE SYSTEM GMK-SPHERIKA TIBIAL TRAY FIXED CEMENTED SIZE 3 R JWH MEDACTA INTERNATIONAL SA 02.07.1203R 2248135 07630030819896

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention