BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/11 MM L

    MDR report key: 7479658 · Received May 2, 2018

    Report

    Report Number
    3005180920-2018-00290
    Event Type
    Injury
    Date Received
    May 2, 2018
    Date of Event
    April 2, 2018
    Report Date
    May 2, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862649
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 02 MAY 2018. LOT 173779: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06 OCTOBER 2017. EXPIRATION DATE: 2022-09-20 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 3 WEEKS AFTER PRIMARY. THE PATHOGEN IS CONFIRMED AS INTER COCCUS. THE SURGEON PERFORMED AN I AND D AND SWAPPED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323369 TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/11 MM L TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 173779 07630030862649

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention