BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/10 MM R

    MDR report key: 7498749 · Received May 9, 2018

    Report

    Report Number
    3005180920-2018-00313
    Event Type
    Injury
    Date Received
    May 9, 2018
    Date of Event
    April 12, 2018
    Report Date
    May 9, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826948
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(6) 2018, LOT 131013: (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(4) 2013. EXPIRATION DATE: (B)(6) 2018. 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

    REVISION SURGERY DUE TO EARLY SIGNS OF INFECTION 10 DAYS AFTER PRIMARY. THE SURGEON WASHED OUT THE KNEE AND SWAPPED THE POLY. THE PATHOGEN IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340227 TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/10 MM R TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 131013 07630030826948

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention