BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 20961926 · Received December 18, 2024

    Report

    Report Number
    3005180920-2024-01056
    Event Type
    Injury
    Date Received
    December 18, 2024
    Date of Event
    November 18, 2024
    Report Date
    December 18, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 29 NOVEMBER 2024: LOT 2112427: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-OCT-2021. EXPIRATION DATE: 2026-10-07. 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. THE SURGEON REVISED LINER HEIGHT, WHICH IS A COMMON PRACTICE TO RESTORE THE JOINT STABILITY. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 0

    AT ABOUT 2 YEARS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY. THE SURGEON REVISED THE 13MM POLY WITH A 17MM POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1719486 GMK SPHERE TOTAL KNEE SYSTEM KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0213FL 2112427

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention