BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA H FEMORAL STEMS

    MDR report key: 23690785 · Received December 2, 2025

    Report

    Report Number
    3005180920-2025-01206
    Event Type
    Injury
    Date Received
    December 2, 2025
    Date of Event
    November 18, 2025
    Report Date
    December 2, 2025
    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 25-11-2025. CUP: VERSAFITCUP 01.26.48MB VERSAFITCUP METALBACK DM D 48 MM (K083116) LOT. 2004775: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-11-2020 EXPIRATION DATE: 2025-11-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. STEM: QUADRA-H 01.12.21SN QUADRA "H" SHORT NECK, CEM.LESS, STD, HAP S.1 (K082792) LOT. 1905426: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-10-2019 EXPIRATION DATE: 2024-09-17. 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. ROOT CAUSE: 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 4 YEARS AND 9 MONTHS FROM PRIMARY, THE PATIENT CAME IN DUE TO A METAL ALLERGY. THE SURGEON REVISED THE MEDACTA STEM, CUP, AND LINER TO A COMPETITOR STEM CUP AND LINER AND REVISED THE MEDACTA HEAD TO A MEDACTA HEAD WITH SLEEVE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2809528 QUADRA H FEMORAL STEMS QUADRA H SHORT NECK, CEMENTLESS, STD, HAP S.1 JDI MEDACTA INTERNATIONAL SA 01.12.21SN 1905426 07630030802614

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Required Intervention