BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 21958375 · Received May 5, 2025

    Report

    Report Number
    3005180920-2025-00390
    Event Type
    Injury
    Date Received
    May 5, 2025
    Date of Event
    April 9, 2025
    Report Date
    May 5, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971262003
    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 17 APRIL 2025: LOT 2412112: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-JULY-2024. EXPIRATION DATE: 2029-06-23. 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. ADDITIONAL IMPLANT INVOLVED, BATCH REVIEW PERFORMED ON 17 APRIL 2025: GMK-SPHERIKA 02.12.3D05R GMK 3DMETAL TIBIAL TRAY SIZE 5R (K221850) LOT 2412112: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-JULY-2024. EXPIRATION DATE: 2029-06-23. 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. 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 4 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING STIFFNESS IN BOTH FLEXION AND EXTENSION. THE SURGEON PROCEEDED TO REMOVE THE INSERT AND TIBIAL TRAY. HE THEN MADE A RECUT OF THE TIBIA AND TRAILED WITH SPHERE TRIALS. ONCE THE KNEE WAS BALANCED HE IMPLANTED A CEMENTED TIBIA WITH A NEW INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1513862 GMK SPHERE TOTAL KNEE SYSTEM TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R E-CROSS JWH MEDACTA INTERNATIONAL SA 02.12.E0510FR 2412112 07630971262003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention