BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/12MM

    MDR report key: 6710491 · Received July 13, 2017

    Report

    Report Number
    3005180920-2017-00374
    Event Type
    Injury
    Date Received
    July 13, 2017
    Date of Event
    June 13, 2017
    Report Date
    July 13, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030817175
    PMA / PMN Number
    K103170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 10 JULY 2017. LOT 151199: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13 OCTOBER 2015. EXPIRATION DATE: 2020-09-27. 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 CAME IN DUE TO SIGNS OF INFECTION. THE INFECTION WAS SUPERFICIAL. THE SURGEON 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
    491647 GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/12MM FIXED TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 151199 07630030817175

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention