BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/13 MM R

    MDR report key: 7605419 · Received June 15, 2018

    Report

    Report Number
    3005180920-2018-00435
    Event Type
    Malfunction
    Date Received
    June 15, 2018
    Date of Event
    May 18, 2018
    Report Date
    June 15, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862540
    PMA / PMN Number
    K140826
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 15 JUNE 2018; LOT 172807: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13 JULY 2017. EXPIRATION DATE: 25.JUNE.2022; 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

    DURING SURGERY THE INSERT WOULD NOT SEAT PROPERLY IN THE TIBIAL IMPLANT. THE SURGEON USED A SECONDARY INSERT COMPLETING THE SURGERY SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446933 TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/13 MM R TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 172807 07630030862540

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other