BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 10905718 · Received November 25, 2020

    Report

    Report Number
    3005180920-2020-00825
    Event Type
    Injury
    Date Received
    November 25, 2020
    Date of Event
    October 26, 2020
    Report Date
    November 25, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030818240
    PMA / PMN Number
    K090988
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 6 NOVEMBER 2020: LOT 1900590: 25 ITEMS MANUFACTURED AND RELEASED ON 20-MAY-2019. EXPIRATION DATE: 2024-05-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 24 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED AFTER 15 DAYS FROM THE PRIMARY SURGERY DUE TO INFECTION. THE SURGEON REVISED THE INSERT AND PERFORMED A WASHOUT (DIAR). THERE WAS NO CULTURES GROWTH FROM THE SWABS TAKEN BUT CLINICALLY THE PATIENT HAS AN INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1364435 GMK-PRIMARY TIBIAL INSERT STD FIXED SIZE 5 / 10 MM TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 02.07.0510SF 1900590 07630030818240

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention