BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA R FEMORAL STEMS

    MDR report key: 24494914 · Received March 3, 2026

    Report

    Report Number
    3005180920-2026-00118
    Event Type
    Injury
    Date Received
    March 3, 2026
    Date of Event
    January 19, 2026
    Report Date
    March 3, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802386
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 19 FEBRUARY 2026. STEM: QUADRA -R 01.12.060 QUADRA R - STEM CEMENT-LESS HAP 12/14 S. 0 (K082792) LOT 167945: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-FEB-2017. EXPIRATION DATE: 22-JAN-2022. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. 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

    THE PATIENT WAS EVALUATED ON AN OUTPATIENT BASIS FOR LEFT HIP PAIN AND CRURALGIA FOLLOWING MULTIPLE REVISION SURGERIES OF THE LEFT TOTAL HIP ARTHROPLASTY. APPROXIMATELY 7 YEARS AND 7 MONTHS AFTER THE PRIMARY, A REVISION SURGERY WAS PERFORMED DUE TO STEM LOOSENING.THE SURGEON REMOVED THE STEM, THE HEAD, AND TWO METALLIC CERCLAGE WIRE FRAGMENTS AT THE FEMORAL SITE. THIS WAS FOLLOWED BY REIMPLANTATION OF A NON-CEMENTED MODULAR CONICAL STEM AND A CERAMIC FEMORAL HEAD, AS WELL AS FIXATION OF THE CORTICAL WINDOW USING THE SUPERCABLE CERCLAGE SYSTEM BY KINAMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52461 QUADRA R FEMORAL STEMS QUADRA R - STEM CEMENT-LESS HAP 12/14 S. 0 JDI MEDACTA INTERNATIONAL SA 01.12.060 167945 07630030802386

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention