BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA H FEMORAL STEMS

    MDR report key: 22194002 · Received June 12, 2025

    Report

    Report Number
    3005180920-2025-00557
    Event Type
    Injury
    Date Received
    June 12, 2025
    Date of Event
    May 19, 2025
    Report Date
    June 12, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802614
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 26 MAY 2025 LOT 1910362: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-MAY-2020. EXPIRATION DATE: 2025-04-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    AT ABOUT 3 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2151663 QUADRA H FEMORAL STEMS QUADRA H CEMENTLESS STEM STANDARD SIZE 1 SHORT NECK JDI MEDACTA INTERNATIONAL SA 01.12.21SN 1910362 07630030802614

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention