BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 21796991 · Received April 8, 2025

    Report

    Report Number
    3005180920-2025-00299
    Event Type
    Injury
    Date Received
    April 8, 2025
    Date of Event
    March 18, 2025
    Report Date
    April 8, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K202022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 25 MARCH 2025: LOT 2012372: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-FEB-2021. EXPIRATION DATE: 2026-01-20. 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. BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    AT ABOUT 2 YEARS 3 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN. WHEN ASSESSING THE PATIENT, THE SURGEON FOUND THAT THE PATIENT'S PAIN WAS IN THE PATELLA TRACKING (REASON UNKNOWN). THE SURGEON RESURFACED THE PATIENT'S NATURAL PATELLA AND ADDED THICKER POLY TO GIVE THE KNEE MORE TENSION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721341 GMK SPHERE TOTAL KNEE SYSTEM GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/11 MM L E-CROSS JWH MEDACTA INTERNATIONAL SA 02.12.E0211FL 2012372

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Required Intervention