BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA H FEMORAL STEM SIZE 3 LAT SHORT NECK

    MDR report key: 4173761 · Received September 25, 2014

    Report

    Report Number
    3006639916-2014-00126
    Event Type
    Injury
    Date Received
    September 25, 2014
    Date of Event
    August 26, 2014
    Report Date
    September 25, 2014
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: QUADRA H CEMENTLESS FEMORAL STEM SIZE 3 LAT SHORT NECK (B)(4)/ LOT 090822/T (B)(4): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECS VALID AT THE TIME OF MFG, INCLUDING WASHING AND STERILIZATION PROCEDURES. (B)(4) STEMS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR INCIDENT. FROM THE DATA COLLECTED, THERE ARE NO EVIDENCE THAT THE EVENT IS DEVICE RELATED.

    Description of Event or Problem · 1

    THE PT PRESENTED WITH A FEMORAL PERI-PROSTHETIC FRACTURE. A REVISION WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596718 QUADRA H FEMORAL STEM SIZE 3 LAT SHORT NECK FEMORAL CEMENTLESS STEM LAT SHORT NECK LZO MEDACTA INTERNATIONAL SA 090822/T

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention