BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY TIBIAL INSERT STD FIXED SIZE 5 / 10 MM

    MDR report key: 11300314 · Received February 9, 2021

    Report

    Report Number
    3005180920-2021-00111
    Event Type
    Injury
    Date Received
    February 9, 2021
    Date of Event
    January 14, 2021
    Report Date
    February 9, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030818240
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 11 DECEMBER 2020: LOT 1910536: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 3-FEB-2020. EXPIRATION DATE: 2025-01-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198992 GMK-PRIMARY TIBIAL INSERT STD FIXED SIZE 5 / 10 MM KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.07.0510SF 1910536 07630030818240

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention