BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA H CEMENTLESS FEMORAL STEM SIZE 4 STD

    MDR report key: 5289419 · Received December 11, 2015

    Report

    Report Number
    3005180920-2015-00320
    Event Type
    Injury
    Date Received
    December 11, 2015
    Date of Event
    November 10, 2015
    Report Date
    February 10, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 04 DEC 2015 THE MEDICAL AFFAIRS DIRECTOR MADE THE FOLLOWING ANALYSIS: THIS THA APPEARS TO HAVE BEEN CORRECTLY PLANNED AND EXECUTED. FOR UNKNOWN REASONS, THE STEM GOT LOCKED DISTALLY AND GAINED SOME RADIOLUCENCY IN THE PROXIMAL HALF, BECOMING MOST LIKELY PAINFUL AND REQUIRING REVISION. I CAN ONLY CLASSIFY IT AS AN IDIOPATHIC LOOSENING, THE ROOT CAUSE REMAINS UNKNOWN. BATCH REVIEW PERFORMED ON 07 DECEMBER 2015: LOT 124027: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19 DECEMBER 2012. EXPIRATION DATE: 2017-11-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. UP TO 10 DEC 2015, NO INFORMATION HAS BEEN RECEIVED YET ABOUT THE REVISION SURGERY. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 14 JANUARY 2016 AND INCLUDES: REVISION SUCCESSFULLY PERFORMED ON (B)(6) 2015. ON 09 FEBRUARY 2016, THE R&D PROJECT MANAGER ANALYSED THE RETURNED IMPLANTS AND COMMENTED AS FOLLOWS: OBSERVING THE FEMORAL STEM, NO PARTICULAR SIGN CAN BE NOTED, EXCEPT ON THE NECK: SUCH SIGNS WAS PROBABLY CAUSED DURING THE REMOVAL PHASE. THE HA ON THE SURFACE OF THE STEM IS REABSORBED. NO BONE CAN BE SEEN ON THE SURFACE OF THE STEM, EXCEPT BONES ON THE DISTAL LATERAL ONE. THE CERAMIC FEMORAL HEAD SHOWS SOME SCRATCHES PROBABLY CAUSED BY THE REVISION SURGERY. IT IS NOT POSSIBLE FROM THE INSPECTION OF THE IMPLANTS TO DETERMINE THE ROOT CAUSE OF THE EVENT. ON 09 FEBRUARY 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT AND HERE ABOVE. ON THE SAME DATE, THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

    EARLY LOOSENING OF STEM 2 YEARS AFTER PRIMARY. REVISION WILL BE PERFORMED ON (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819792 QUADRA H CEMENTLESS FEMORAL STEM SIZE 4 STD CEMENTLESS FEMORAL STEM JDI MEDACTA INTERNATIONAL SA 124027

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention