BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/12MM

    MDR report key: 5906609 · Received August 26, 2016

    Report

    Report Number
    3005180920-2016-00432
    Event Type
    Injury
    Date Received
    August 26, 2016
    Date of Event
    July 27, 2016
    Report Date
    August 26, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K103170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 05 AUGUST 2016: LOT 121807: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02 MAY 2012; EXPIRATION DATE: 2017-03-31. NO ANOMALIES FOUND RELATED TO THE ISSUE. 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 DUE TO SIGNS OF INFECTION. THE INFECTION IS CONFIRMED, THE PATIENT TESTED POSITIVE FOR (B)(6). THE SURGEON PERFORMED AN I&D AND SWAPPED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561110 GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/12MM FIXED TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 121807

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention