BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK REVISION TOTAL KNEE SYSTEM

    MDR report key: 22505896 · Received July 15, 2025

    Report

    Report Number
    3005180920-2025-00662
    Event Type
    Injury
    Date Received
    July 15, 2025
    Date of Event
    June 23, 2025
    Report Date
    July 15, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030816499
    PMA / PMN Number
    K103170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 30 JUNE 2025 LOT 2421682: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20/09/2024. EXPIRATION DATE: 04/09/2029. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.

    Description of Event or Problem · 0

    AFTER 1 MONTH FROM THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND POLY SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1739458 GMK REVISION TOTAL KNEE SYSTEM GMK-SPHERE 02.07.0210SCF INSERT SEMICONSTRAINED 10MM S2 JWH MEDACTA INTERNATIONAL SA 02.07.0210SCF 2421682 07630030816499

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention