BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 6282443 · Received January 27, 2017

    Report

    Report Number
    3005180920-2017-00003
    Event Type
    Injury
    Date Received
    January 27, 2017
    Date of Event
    December 29, 2016
    Report Date
    January 27, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 25 JANUARY 2017. LOT 150798: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20 AUGUST 2015. EXPIRATION DATE: 2020-06-30. 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 WAS COMPLAINING OF PAIN. THE SURGEON LOOKED AT IT AND DETERMINED THAT IT WAS DUE TO AN INFECTION. THE SURGEON PERFORMED A REVISION SURGERY TO REMOVE THE INSERT AND CLEAN THE INFECTION AREA. THE SURGEON VERIFIED THE IMPLANTS WERE STILL STABLE. ONLY THE LINER WAS REPLACED. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65009 GMK-PRIMARY TIBIAL INSERT FIXED SIZE 5 / 10 MM STD TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 150798

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention