BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK REVISION TOTAL KNEE SYSTEM

    MDR report key: 20469414 · Received October 17, 2024

    Report

    Report Number
    3005180920-2024-00844
    Event Type
    Injury
    Date Received
    October 17, 2024
    Date of Event
    September 18, 2024
    Report Date
    October 17, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030816710
    PMA / PMN Number
    K103170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 17 OCT 2024 LOT 2241244: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-DEC-2022. EXPIRATION DATE: 2027-11-27. 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.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 1 MONTH AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1368101 GMK REVISION TOTAL KNEE SYSTEM TIBIAL INSERT SC FIXED 14MM, SIZE 2 JWH MEDACTA INTERNATIONAL SA 02.07.0214SCF 2241244 07630030816710

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention