BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 3/10MM

    MDR report key: 8544431 · Received April 24, 2019

    Report

    Report Number
    3005180920-2019-00303
    Event Type
    Injury
    Date Received
    April 24, 2019
    Date of Event
    March 23, 2019
    Report Date
    April 24, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030817069
    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 THE 23 APRIL 2019: LOT 183544: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-AUG-2018. EXPIRATION DATE: 2023-07-23. 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

    REVISION SURGERY AFTER ONE MONTH FROM THE PRIMARY DUE TO SIGNS OF INFECTION (THE PATHOGEN IS UNKNOWN). THE SURGEON PERFORMED AN I&D AND POLY SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339325 GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 3/10MM KNEE POLYETHYLENE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 183544 07630030817069

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention