BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA H FEMORAL STEM

    MDR report key: 2508565 · Received March 20, 2012

    Report

    Report Number
    3005180920-2012-00015
    Event Type
    Injury
    Date Received
    March 20, 2012
    Date of Event
    February 21, 2012
    Report Date
    March 20, 2012
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: QUADRA H FEMORAL STEM SIZE 6 STD - REF. 01.12.026 / LOT 112599 (35 STEMS PRODUCED): ALL PARAMETERS WERE FOUND TO BE CONFORMING TO SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. THE WASHING CYCLE FOR METAL COMPONENTS WAS RUN ACCORDING TO SPECIFICATIONS AND NO ALARM OR DEVIATION OCCURRED DURING OPERATION. THE STERILIZATION CYCLE WAS PERFORMED ACCORDING TO SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. AROUND 11 STEMS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO INCIDENTS HAVE BEEN REPORTED UP TO NOW. THE PROBLEM OCCURRED IS HIGHLY LIKELY ASSOCIATED TO A BAD POSITIONING OF THE STEM IN PER OP, AS NOTICED FROM THE X-RAYS RECEIVED. THE EVENT IS THOUGHT TO BE NOT DEVICE RELATED, BUT IT IS PROBABLY DUE TO A USE ERROR.

    Description of Event or Problem · 1

    REVISION SURGERY 1 DAY POST OP, DUE TO FEMUR FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUADRA H FEMORAL STEM FEMORAL STEM SIZE 6 STANDARD JDI MEDACTA INTERNATIONAL SA 112599

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention BY CERAMTEC (B)(4) AND NOT MARKETED IN THE USA| BIOLOX DELTA CERAMIC HEAD 32 SIZE L: MANUFACTURED