BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK 3D METAL TIBIAL TRAY

    MDR report key: 22727958 · Received August 6, 2025

    Report

    Report Number
    3005180920-2025-00752
    Event Type
    Injury
    Date Received
    August 6, 2025
    Date of Event
    July 23, 2025
    Report Date
    August 6, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630345710901
    PMA / PMN Number
    K221850
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 29 JULY 2025. GMK-SPHERE 02.12.3D34R GMK 3DMETAL TIBIAL TRAY SIZE T3I4R (K221850) LOT. 2432770: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-FEB-2025. EXPIRATION DATE: 06-FEB-2030. NO ANOMALIES WERE 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 COMPONENT INVOLVED: GMK-SPHERE 02.12.E0411FR GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 4R - 11MM (K202022) LOT. 2425473: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-OCT-2024. EXPIRATION DATE: 15-OCT-2029. NO ANOMALIES WERE 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. CONCLUSIONS: 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

    FOURTEEN (14) DAYS AFTER THE PRIMARY SURGERY, THE PATIENT REPORTED INSTABILITY AND DISCOMFORT, WITH AN UNKNOWN CAUSE. THE SURGEON FOUND THE TIBIA TO BE SOFT AND COLLAPSED DUE TO OSTEOPENIC BONE. A TIBIAL REVISION WAS PERFORMED, AND THE INSERT WAS UPSIZED FROM 11MM TO 14MM TO ADDRESS THE INSTABILITY. THE SURGERY WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1765915 GMK 3D METAL TIBIAL TRAY 3DMETAL TIBIAL TRAY SIZE T3I4R JWH MEDACTA INTERNATIONAL SA 02.12.3D34R 2432770 07630345710901

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention