BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FIXED TIBIAL INSERT SC SIZE 6/20MM

    MDR report key: 17982989 · Received October 23, 2023

    Report

    Report Number
    3005180920-2023-00833
    Event Type
    Injury
    Date Received
    October 23, 2023
    Date of Event
    September 29, 2023
    Report Date
    October 23, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819254
    PMA / PMN Number
    K103170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2023. LOT 189556: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-MAR-2019. EXPIRATION DATE: 2024-FEB-19. 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. OTHER IMPLANTS INVOLVED, BATCH REVIEW PERFORMED ON (B)(6) 2023: GMK-REVISION 02.07.0686R REVISION FIXED TIBIAL TRAY CEMENTED SIZE 6 R (K123721) LOT. 1811755: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JUN-2019. EXPIRATION DATE: 2024-MAY-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. GMK-REVISION 02.07.2405R FEMUR REVISION PS SIZE 5 R (K102437) LOT 1909692: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-MAR-2020. EXPIRATION DATE: 2025-FEB-23. 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.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. ABOUT 9 MONTHS FROM THE FIRST REVISION SURGERY, THE SURGEON REVISED THE PATIENT FROM GMK-REVISION TO GMK-HINGE COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT HAD COMPETITOR COMPONENTS PRIOR TO MEDACTA REVISION COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    962197 GMK-REVISION FIXED TIBIAL INSERT SC SIZE 6/20MM KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 189556 07630030819254

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention