BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER Ø36/F

    MDR report key: 8771375 · Received July 9, 2019

    Report

    Report Number
    3005180920-2019-00556
    Event Type
    Injury
    Date Received
    July 9, 2019
    Date of Event
    June 11, 2019
    Report Date
    July 9, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812132
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 21.JUNE.2019: LOT 170131: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27 MAR 2017. EXPIRATION DATE: 2022-03-09. 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

    SECOND REVISION SURGERY PERFORMED 2 MONTHS AFTER THE PREVIOUS REVISION DUE TO LEG LENGTH DISCREPANCY, PRIMARY PERFORMED ON (B)(6) 2017. THE SURGEON REVISED THE COMPETITOR'S HEAD AND MEDACTA LINER. THE POSITION OF A COMPETITOR STEM WAS LOW AND IT'S UNCLEAR IF THIS WAS HOW THE STEM ORIGINALLY WAS IMPLANTED OR IF IT SETTLED OVER TIME. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566719 LINER: MPACT FLAT PE HC LINER Ø36/F FLAT PE HC LINER LPH MEDACTA INTERNATIONAL SA 170131 07630030812132

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention