BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 8

    MDR report key: 11009860 · Received December 15, 2020

    Report

    Report Number
    3005180920-2020-00894
    Event Type
    Injury
    Date Received
    December 15, 2020
    Date of Event
    November 16, 2020
    Report Date
    December 15, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802096
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 27 NOVEMBER 2020: LOT 2002652: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-JUL-2020. EXPIRATION DATE: 2025-07-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    4 DAYS AFTER THE PRIMARY SURGERY, THE STEM SLID A LITTLE BIT DEEPER INTO THE BONE. ON X-RAYS A LONGITUDINAL FRACTURE OF THE FEMUR WAS DISCOVERED. THE SURGEON EXPLANTED THE STEM AND HE DID 5 CERCLAGES AROUND THE FEMUR AND IMPLANTED A QUADRA R STEM SIZE 6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1478357 STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 8 CEMENTLESS HIP STEM JDI MEDACTA INTERNATIONAL SA 01.12.028 2002652 07630030802096

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention