BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 4/14 MM LEFT

    MDR report key: 6965051 · Received October 20, 2017

    Report

    Report Number
    3005180920-2017-00604
    Event Type
    Injury
    Date Received
    October 20, 2017
    Date of Event
    September 21, 2017
    Report Date
    October 20, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826610
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 17 OCTOBER 2017. LOT 141019: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14 MAY 2014. EXPIRATION DATE: 2019-03-31. 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 SURGEON PERFORMED AN I&D AND SWAPPED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744598 GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 4/14 MM LEFT TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 141019 07630030826610

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention