BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 22529150 · Received July 17, 2025

    Report

    Report Number
    3005180920-2025-00641
    Event Type
    Injury
    Date Received
    July 17, 2025
    Date of Event
    June 26, 2025
    Report Date
    July 16, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862632
    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 27-06-2025. GMK-SPHERE 02.12.0413FR GMK-SPHERE TIBIAL INSERT - FLEX S4R - 13 MM (K140826) LOT. 179697: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-04-2018 EXPIRATION DATE: 2023-04-10. 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. 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

    THE PATIENT CAME IN REPORTING INSTABILITY, NO INFORMATION ON THE PRIMARY SURGERY IS AVAILABLE. THE SURGEON REVISED TO A THICKER POLY, 13MM TO 20MM, AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808515 GMK SPHERE TOTAL KNEE SYSTEM GMK-SPHERE TIBIAL INSERT - FLEX S4R - 13 MM JWH MEDACTA INTERNATIONAL SA 02.12.0413FR 179697 07630030862632

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention