BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 23291309 · Received October 15, 2025

    Report

    Report Number
    3005180920-2025-00968
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    September 15, 2025
    Report Date
    October 14, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971261600
    PMA / PMN Number
    K202022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 19 SEPTEMBER 2025 LOT 2242954: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-JAN-2024. EXPIRATION DATE: 2028-02-01. 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. 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 HAD KNEE INSTABILITY AND THE CAUSE IS UNKNOWN. AT ABOUT 1 YEAR AND 6 MONTHS POST PRIMARY THE SURGEON UPSIZED THE POLY FROM 12MM TO 13MM FOR INCREASED STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2019636 GMK SPHERE TOTAL KNEE SYSTEM GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 3R - 12MM JWH MEDACTA INTERNATIONAL SA 02.12.E0312FR 2242954 07630971261600

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention