BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL INSERT FIXED SPHERE FLEX SIZE 1/14 MM L

    MDR report key: 7905422 · Received September 25, 2018

    Report

    Report Number
    3005180920-2018-00723
    Event Type
    Injury
    Date Received
    September 25, 2018
    Date of Event
    September 11, 2018
    Report Date
    September 25, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826016
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 24 SEPTEMBER 2018; LOT 172585: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24 FEBRUARY 2014. EXPIRATION DATE: 2019-01-31; 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

    INFORMATION RECEIVED ON AUG 28, 2018: THE PATIENT CAME IN COMPLAINING OF INSTABILITY 1 YEAR AND 6 MONTHS AFTER PRIMARY. THE SURGEON PLANS TO REVISE THE PATIENT ON (B)(6) 2018. MORE INFORMATION TO FOLLOW THE CASE. UPDATE (B)(6) 2018 : THE LINER WAS REVISED. THE LINER IMPLANTED DURING THE REVISION IS 02.12.0120FL SPHERE INSERT FLEX LEFT 20MM S1 154729. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748327 TIBIAL INSERT FIXED SPHERE FLEX SIZE 1/14 MM L TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 135729 07630030826016

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention