BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/14 MM R

    MDR report key: 7206144 · Received January 19, 2018

    Report

    Report Number
    3005180920-2017-00863
    Event Type
    Injury
    Date Received
    January 19, 2018
    Date of Event
    December 22, 2017
    Report Date
    January 19, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826825
    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 19 JANUARY 2018 LOT 152458: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10 NOV 2015. EXPIRATION DATE: 2020-10-19 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

    ONE YEAR AND 1 MONTH AFTER PRIMARY THE PATIENT CAME IN COMPLAINING OF INSTABILITY. THE CAUSE OF THE INSTABILITY IS UNKNOWN. NO TRAUMA REPORTED. THE SURGEON REVISED SUCCESSFULLY A 14MM POLY FOR A 17MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49521 TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/14 MM R TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 152458 07630030826825

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention