BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA S LAT FEMORAL STEM

    MDR report key: 2613766 · Received May 13, 2009

    Report

    Report Number
    3005180920-2009-00003
    Event Type
    Injury
    Date Received
    May 13, 2009
    Date of Event
    April 14, 2009
    Report Date
    April 14, 2009
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    PMA / PMN Number
    K072857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MFG RECORDS AND QUALITY DOCUMENTS WERE REVIEWED. THE MFG AND QUALITY DOCUMENTS REVIEW CONFIRMED THAT ALL IMPLANTS RELEASED TO THE FIELD OF THE LOT NUMBER 073137 (B)(4) WERE CONFORMING TO SPECIFICATIONS VALID AT THE TIME OF MANUFACTURE. FEMUR FRACTURES ARE A KNOWN POSSIBLE COMPLICATION OF TOTAL HIP ARTHROPLASTY.

    Description of Event or Problem · 1

    SURGEON STARTED WITH THE STANDARD SIZE 0 BROACH AND VISUALLY NOTICED A FRACTURE OF THE GREATER TROCHANTER. HE CONTINUED BROACHING UP TO A SIZE 4. THE FINAL IMPLANT WAS A SIZE 3 AND THE FRACTURE WAS CABLED. THE PT IS LIMITING THEIR WEIGHT BEARING ACTIVITY. THERE IS NO ADDITIONAL MEDICAL INTERVENTION OF REVISION SURGERY EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUADRA S LAT FEMORAL STEM FEMORAL STEM JDI MEDACTA INTERNATIONAL SA NA 073137

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention