BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 24482227 · Received March 2, 2026

    Report

    Report Number
    3005180920-2026-00150
    Event Type
    Injury
    Date Received
    March 2, 2026
    Date of Event
    February 5, 2026
    Report Date
    March 2, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630040707190
    PMA / PMN Number
    K181635
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 11 FEBRUARY 2026. LOT 2110156: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-SEP-2021. EXPIRATION DATE: 2026-09-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL 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 MOBILITY. 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 2 YEARS 10 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO LIMITED RANGE OF MOTION AND THE CAUSE IS UNKNOWN. THE SURGEON PERFORMED A SYNOVECTOMY AND REVISED THE PATIENT`S NATURAL PATELLA AND UPSIZED THE INSERT FROM 10MM TO 12MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621365 GMK SPHERE TOTAL KNEE SYSTEM TIBIAL INSERT FIXED SPHERE CR SIZE2/10 MM L JWH MEDACTA INTERNATIONAL SA 02.12.0210CRL 2110156 07630040707190

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention