BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA H CEMENTLESS FEMORAL STEM

    MDR report key: 3080639 · Received April 5, 2013

    Report

    Report Number
    3005180920-2013-00030
    Event Type
    Injury
    Date Received
    April 5, 2013
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    PMA / PMN Number
    K082792
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: QUADRA H CEMENTLESS FEMORAL STEM SIZE 1 STD: REF. (B)(4) / LOT 071629 (B)(4) ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MFG. 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. (B)(4). FROM THE DATA COLLECTED, THERE ARE NO EVIDENCES THAT THE EVENT IS DEVICE RELATED.

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO LOOSENING OF A STEM QUADRA H 5 YEARS AND 4 MONTHS POST OP. PLEASE REFERENCE IMPORTER REPORT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140312 QUADRA H CEMENTLESS FEMORAL STEM FEMORAL STEM SIZE 1 STANDARD JDI MEDACTA INTERNATIONAL SA

    Patients

    Seq Age Sex Outcome Treatment
    1