BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 25148963 · Received May 12, 2026

    Report

    Report Number
    3005180920-2026-00404
    Event Type
    Injury
    Date Received
    May 12, 2026
    Date of Event
    April 20, 2026
    Report Date
    May 12, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826610
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 23 APRIL 2026 LOT: 2113262: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-NOV-2021. EXPIRATION DATE: 2026-11-02. 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. ROOT CAUSE: THE SURGEON REVISED LINER HEIGHT, WHICH IS A COMMON PRACTICE TO RESTORE THE JOINT STABILITY, AND RESURFACED THE PATIENT'S NATURAL PATELLA, WHICH IS A COMMON PRACTICE IN CASE OF NOT PATELLA RESURFACING DURING PRIMARY SURGERY. 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 3 YEARS 8 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN PRESENTING ANTERIOR KNEE PAIN AND INSTABILITY AND THE CAUSE IS UNKNOWN. THERE WERE NO INDICATIONS OF TRAUMA. THE SURGEON REVISED THE PATIENT`S NATURAL PATELLA AND REVISED THE 14MM INSERT TO 17MM INSERT TO ADDRESS THE INSTABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376854 GMK SPHERE TOTAL KNEE SYSTEM GMK-SPHERE TIBIAL INSERT - FLEX S4L - 14 MM JWH MEDACTA INTERNATIONAL SA 02.12.0414FL 2113262 07630030826610

    Patients

    Seq Age Sex Outcome Treatment
    1