BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 25185351 · Received May 15, 2026

    Report

    Report Number
    3005180920-2026-00469
    Event Type
    Injury
    Date Received
    May 15, 2026
    Date of Event
    April 29, 2026
    Report Date
    May 15, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826337
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 04 MAY 2026 GMK-SPHERE 02.12.0310FL GMK-SPHERE TIBIAL INSERT - FLEX S3L - 10 MM (K121416) LOT 1810372: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-MAR-2019. EXPIRATION DATE: 20-FEB-2024. 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. ROOT CAUSE: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 6 YEARS AND 10 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING INSTABILITY AND A "CLICKING" NOISE IN KNEE AND THE CAUSE IS UNKNOWN. THERE WAS NO REPORTS OF TRAUMA. THE SURGEON REVISED THE INSERT (FROM 10MM TO 14MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488811 GMK SPHERE TOTAL KNEE SYSTEM GMK-SPHERE TIBIAL INSERT - FLEX S3L - 10 MM JWH MEDACTA INTERNATIONAL SA 02.12.0310FL 1810372 07630030826337

    Patients

    Seq Age Sex Outcome Treatment
    1