BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/17MM

    MDR report key: 19039584 · Received April 4, 2024

    Report

    Report Number
    3005180920-2024-00183
    Event Type
    Injury
    Date Received
    April 4, 2024
    Date of Event
    March 7, 2024
    Report Date
    April 4, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030817991
    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 14 MARCH 2024. LOT 1903723: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-JULY-2019. EXPIRATION DATE: 2024-07-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH TWO OTHER SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 2 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. 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
    83436 GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/17MM KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 1903723 07630030817991

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention