BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA-H CEMENTLESS, HA COATED STEM SIZE 3 LAT, SHORT NECK

    MDR report key: 6124778 · Received November 23, 2016

    Report

    Report Number
    3005180920-2016-00603
    Event Type
    Injury
    Date Received
    November 23, 2016
    Date of Event
    October 16, 2016
    Report Date
    November 23, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(6) 2016. LOT 090822/T: (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2015. EXPIRATION DATE: (B)(6) 2020. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, THIS IS THE ONLY ITEM SOLD OF THIS LOT. NOT AVAILABLE.

    Description of Event or Problem · 1

    THE PATIENT COMPLAINED OF PAIN WHILST AT HOME. SHE CONTACTED SURGEON WHO ADMITTED THE PATIENT AND X-RAY SHOWED SUBSIDED FEMORAL STEM. CT SHOWED NON DISPLACED FEMORAL FRACTURE. EVENT CONFIRMED NOT RELATED TO A TRAUMA. THE STEM WAS REVISED TO A MODULAR LONG STEM COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775701 QUADRA-H CEMENTLESS, HA COATED STEM SIZE 3 LAT, SHORT NECK CEMENTLESS FEMORAL STEM JDI MEDACTA INTERNATIONAL SA 090822/T

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention