BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA H FEMORAL STEMS

    MDR report key: 24494918 · Received March 3, 2026

    Report

    Report Number
    3005180920-2026-00172
    Event Type
    Injury
    Date Received
    March 3, 2026
    Date of Event
    February 11, 2026
    Report Date
    March 3, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802614
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 11 FEBRUARY 2026. STEM: QUADRA-H 01.12.21SN QUADRA " H" SHORT NECK, CEM.LESS, STD, HAP S.1 (K082792) LOT 125040: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-FEB-2013. EXPIRATION DATE: 31-DEC-2017. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION: 13 YEARS AFTER PRIMARY CEMENTLESS THA, THE STEM GETS LOOSE AND PAINFUL AND REVISION IS TO BE UNDERTAKEN. BOTH STEMS WERE PLACED VERY CONSERVATIVELY, WITH MINIMUM BONE SACRIFICE, AND IT&SIZE39;S QUITE REMARKABLE THAT IT HELD FOR SO MANY YEARS: EVIDENTLY THE CRAFTMANSHIP OF THE PRIMARY IMPLANT WAS VERY GOOD. IT IS ALSO POSSIBLE THAT, GIVEN THE AGE AND THE WEIGHT OF THE PATIENT, THE BONE HAS CHANGED SHAPE IN THE PAST YEARS AND THE STEM COULD NOT FOLLOW IT. THERE&SIZE39;S NO REASON TO SUSPECT A DEFECTIVE OR MALFUNCTIONING DEVICE AT THE ORIGIN OF THIS LATE LOOSENING. ROOT CAUSE:ASEPTIC LOOSENING IS A POSSIBLE LITERATURE-DESCRIBED ADVERSE EVENT AFTER PRIMARY JOINT ARTHROPLASTIES AND CAUSES ARE OFTEN UNKNOWN. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. NO PREVIOUS CASE HAS BEEN ADDRESSED TO A DEVICE DESIGN OR MANUFACTURING RELATED ROOT CAUSE.

    Description of Event or Problem · 0

    AT ABOUT 12 YEAR AND 11 MONTH FROM THE PRIMARY,THE PATIENT CAME REPORTING HIPPAIN DUE TO EVIDENT STEM LOOSENING.DURING THE REVISION SURGERY, THE HEAD, STEM, AND LINER WERE REMOVED, WHILE THE CUP WAS RETAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559010 QUADRA H FEMORAL STEMS QUADRA H SHORT NECK, CEM.LESS, STD, HAP S.1 JDI MEDACTA INTERNATIONAL SA 01.12.21SN 125040 07630030802614

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention