BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA H LAT FEMORAL STEM

    MDR report key: 2613799 · Received December 28, 2009

    Report

    Report Number
    3005180920-2009-00013
    Event Type
    Injury
    Date Received
    December 28, 2009
    Date of Event
    November 27, 2009
    Report Date
    November 27, 2009
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    JDI
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MFG RECORDS AND QUALITY DOCUMENTS WERE REVIEWED. THE MFG AND QUALITY DOCUMENT REVIEW CONFIRMED THAT ALL FEMORAL STEMS RELEASED TO THE FIELD OF LOT NUMBER 080531 (B)(4) CONFORM TO THE SPECIFICATION VALID AT THE TIME OF MANUFACTURE. THE STERILIZATION CYCLE FOR LOT NUMBER 080531 WAS PERFORMED ACCORDING TO THE SPECIFICATION VALID AT THE TIME OF PRODUCTION. FOUR OTHER CASES OF INFECTION WERE REPORTED IN THE SAME HOSPITAL. MEDACTA INTERNATIONAL USED TWO EXTERNAL SURGEONS TO INVESTIGATE THE POTENTIAL CORRELATION BETWEEN THE INFECTIONS OBSERVED AND THE MEDIAL DEVICE IMPLANTED. BOTH SURGEONS BELIEVE THE INFECTION WAS PROBABLY NOT DEVICE RELATED. IT MAY BE RELATED TO SUTURE WIRING PROCEDURE OR DRAPING PROCEDURE. IF THERE IS NEW INFO LEARNED ABOUT THE INCIDENT OR ITS CAUSE, A FOLLOW UP REPORT WILL BE SUBMITTED. INFECTION IS A KNOWN RISK OF TOTAL HIP ARTHROPLASTY AND IS LISTED IN THE DEVICE LABELING.

    Description of Event or Problem · 1

    THE PT HAD PAIN AND DEVELOPED A JOINT INFECTION AFTER THE PRIMARY SURGERY. THE ENTIRE SET OF FIVE IMPLANTS WERE EXPLANTED. AT THE TIME OF THE COMPLAINT THE PT HAD A CEMENT SPACER IN THE JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUADRA H LAT FEMORAL STEM FEMORAL STEM JDI MEDACTA INTERNATIONAL, SA NA 080531

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention MEDACTA FEMORAL HEAD: 01.25.011, LOT 073192| LOT 080037| VERSAFITCUP CC ACETABULAR SHELL: 01.26.50MBT,| LOT 080052| VERSAFITCUP CC FLAT PE HC LINER: 01.26.2839HCT,