BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 8518690 · Received April 16, 2019

    Report

    Report Number
    3005180920-2019-00282
    Event Type
    Injury
    Date Received
    April 16, 2019
    Date of Event
    March 14, 2019
    Report Date
    April 16, 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 16 APRIL 2019: LOT 121919: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-AUG-2012. EXPIRATION DATE: 2017-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION 6 YEARS AFTER PRIMARY SURGERY, 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
    313040 GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 3/10MM KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 121919 07630030817069

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention