BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL INSERT FIXED SPHERE FLEX SIZE3/10 MM R

    MDR report key: 7341164 · Received March 15, 2018

    Report

    Report Number
    3005180920-2018-00144
    Event Type
    Injury
    Date Received
    March 15, 2018
    Date of Event
    February 13, 2018
    Report Date
    March 15, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826344
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 15 MARCH 2018; LOT 141027: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 MARCH 2014. EXPIRATION DATE: 2019-02-28 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 PATHOGEN IS UNKNOWN. THE SURGEON SWAPPED THE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184852 TIBIAL INSERT FIXED SPHERE FLEX SIZE3/10 MM R TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 141027 07630030826344

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention