BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA H FEMORAL STEM

    MDR report key: 1970163 · Received January 14, 2011

    Report

    Report Number
    3005180920-2010-00023
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    September 27, 2010
    Report Date
    January 11, 2011
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: QUADRA H FEMORAL STEM SIZE 3 - (B)(4)/LOT 101435. THE QUALITY AND MANUFACTURING DOCUMENTS (BATCH RECORD) WERE REVIEWED FOR THE LOT 101435 (10 PIECES PRODUCED): ALL PARAMETERS CONCERNING THE MANUFACTURING PROCESS STEPS WERE FOUND TO BE CONFORMING TO SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. SEVEN PIECES OF THIS LOT WERE ALREADY IMPLANTED AND NO OTHER INCIDENTS WERE REPORTED UP TO NOW. (B)(4). THERE ARE NO EVIDENCES THAT THE FRACTURE IS DEVICE RELATED; THIS INJURY IS A KNOWN COMPLICATION OF TOTAL HIP ARTHROPLASTY.

    Description of Event or Problem · 1

    UPON IMPACTING THE DEFINITIVE STEM, THE SURGEON CRACKED THE PROXIMAL FEMUR. HE SECURED THE FEMUR WITH A DALL MILES CABLE AND FINISHED THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUADRA H FEMORAL STEM FEMORAL STEM SIDE 3 STANDARD JDI MEDACTA INTERNATIONAL SA 101435

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention