BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 25275469 · Received May 26, 2026

    Report

    Report Number
    3005180920-2026-00486
    Event Type
    Injury
    Date Received
    May 26, 2026
    Date of Event
    May 5, 2026
    Report Date
    May 26, 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 11 MAY 2026: LOT: 1903248: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JUL-2019. EXPIRATION DATE: 2024-JUL-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE 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 AND RESURFACED THE PATELLA BONE 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 PAIN DUE TO HYPER EXTENSION AND THE CAUSE IS UNKNOWN. AT ABOUT 6 YEARS AND 6 MONTHS POST PRIMARY THE SURGEON REVISED THE PATIENT`S NATURAL PATELLA AND REVISED THE FLEX S3L - 10MM INSERT TO A FLEX 3L - 14MM INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578258 GMK SPHERE TOTAL KNEE SYSTEM GMK-SPHERE TIBIAL INSERT - FLEX S3L - 10 MM JWH MEDACTA INTERNATIONAL SA 02.12.0310FL 1903248 07630030826337

    Patients

    Seq Age Sex Outcome Treatment
    1