BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK 3D METAL TIBIAL TRAY

    MDR report key: 22000383 · Received May 12, 2025

    Report

    Report Number
    3005180920-2025-00396
    Event Type
    Injury
    Date Received
    May 12, 2025
    Date of Event
    April 9, 2025
    Report Date
    May 12, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630345710840
    PMA / PMN Number
    K221850
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 17 APRIL 2025. LOT 2343537: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-FEB-2024. EXPIRATION DATE: 2029-02-01. 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 COMPONENTS REVISED AND INVOLVED: BATCH REVIEW PERFORMED ON 17 APRIL 2025. GMK-SPHERIKA 02.12.KA165R GMK SPHERIKA FEMUR POROUS TIGROWTHC+HA S5R (K223548) LOT. 2400553: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-SEPT-2024. EXPIRATION DATE: 2029-07-28. 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. 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

    AT 6 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A METAL ALLERGY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1825762 GMK 3D METAL TIBIAL TRAY 3DMETAL TIBIAL TRAY SIZE 4R JWH MEDACTA INTERNATIONAL SA 02.12.3D04R 2343537 07630345710840

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention