BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK

    MDR report key: 21687575 · Received March 25, 2025

    Report

    Report Number
    3005180920-2025-00249
    Event Type
    Injury
    Date Received
    March 25, 2025
    Date of Event
    March 3, 2025
    Report Date
    March 25, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971260986
    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 10 MARCH 2025. LOT: 2409781: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-JUNE-2024. EXPIRATION DATE: 2029-05-27. 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 REVISED. BATCH REVIEW PERFORMED ON 10 MARCH 2025 ON GMK-SPHERE 02.12. E0417FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/17 MM R E-CROSS (K202022) LOT. 2102431. LOT: 2102431: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-MAY-2021. EXPIRATION DATE: 2026-04-22. 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. THE SURGEON REVISED LINER HEIGHT, 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

    AT ABOUT 2 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATED PATELLA IMPLANT AND KNEE INSTABILITY. THE SURGEON REVISED THE 17MM POLY WITH A 20MM POLY AND PERFORMED A LATERAL RELEASE AND VMO ADVANCEMENT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1696365 GMK GMK-SPHERE PATELLA RESURFACING SIZE 2 E-CROSS JWH MEDACTA INTERNATIONAL SA 02.12.E002RP 2409781 07630971260986

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention