BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA C FEMORAL STEM SIZE 2

    MDR report key: 2824151 · Received October 22, 2012

    Report

    Report Number
    3005180920-2012-00069
    Event Type
    Injury
    Date Received
    October 22, 2012
    Date of Event
    September 28, 2012
    Report Date
    October 22, 2012
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    LZO
    PMA / PMN Number
    K083558
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: QUADRA C FEMORAL STEM SIZE 2 CEMENTED: (B)(4) / LOT 083336 (40 STEMS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MFG, INCLUDING WASHING AND STERILIZATION CYCLES. TWENTY STEMS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED UP TO NOW. VERSAFITCUP CC LINER 0 28/C: (B)(4) / LOT 122073 (70 LINERS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MFG, INCLUDING WASHING AND STERILIZATION CYCLES. THIRTY TWO LINERS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED UP TO NOW. VERSAFITCUP CC LIGHT CUP (NOT MARKETED IN THE USA): (B)(4) / LOT 113291 (60 CUPS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECS VALID AT THE TIME OF MANUFACTURING, INCLUDING WASHING AND STERILIZATION CYCLES. THIRTY FIVE CUPS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED UP TO NOW. ON THE BASIS OF THE DATA COLLECTED, A DEVICE INVOLVEMENT IN THE INFECTION IS HIGHLY UNLIKELY.

    Description of Event or Problem · 1

    THE PT DEVELOPED AN INFECTION: ACCORDING TO THE SURGEON'S OPINION DUE TO THE RADIATIONS THAT WEAKENED HER IMMUNE SYSTEM. SHE DEVELOPED AN INFECTION ALSO WHEN SHE UNDERWENT THE FIRST THA ON THE OTHER LEG, WITH NO MEDACTA IMPLANTS. THE FEMUR BROKE DURING REVISION SURGERY DUE TO THE VERY SOFT BONE OF THE PT. THE BACK PART OF TROCHANTER IS BROKEN. IT WAS NOT POSSIBLE TO REMOVE THE CEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUADRA C FEMORAL STEM SIZE 2 FEMORAL CEMENTED STEM LZO MEDACTA INTERNATIONAL, SA 083336

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention LOT 122073 (K103352)| VERSAFITCUP CC LINER (B)(4)| SHELL AND CERAMIC HEAD NOT MARKETED IN USA