BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 24343888 · Received February 16, 2026

    Report

    Report Number
    3005180920-2026-00093
    Event Type
    Injury
    Date Received
    February 16, 2026
    Date of Event
    January 21, 2026
    Report Date
    February 16, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862540
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 28 JANUARY 2026 LOT 173797: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-OCT-2017. EXPIRATION DATE: 16-OCT-2022. 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

    THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. ABOUT 6 YEAR AND 3 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON UPSIZED THE INSERT FROM 11MM TO 13MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405971 GMK SPHERE TOTAL KNEE SYSTEM GMK-SPHERE TIBIAL INSERT - FLEX S2R - 11 MM JWH MEDACTA INTERNATIONAL SA 02.12.0211FR 173797 07630030862540

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention