BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 2

    MDR report key: 10746078 · Received October 28, 2020

    Report

    Report Number
    3005180920-2020-00746
    Event Type
    Injury
    Date Received
    October 28, 2020
    Date of Event
    September 28, 2020
    Report Date
    October 28, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802034
    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 02 APRIL 2020: LOT 162927: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-AUG-2016. EXPIRATION DATE: 2021-07-18. 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. PRELIMINARY INVESTIGATION PERFORMED BY R&D HIP PROJECT MANAGER: PRELIMINARY INVESTIGATION SEEMS TO HIGHLIGHT RESIDUAL HA ON THE STEM AND BONE RESIDUAL. HOWEVER, IMPLANTS SHOW EXTENSIVE BIOLOGICAL FLUIDS COVERAGE AND FROM THE PRELIMINARY INVESTIGATION IT IS NOT POSSIBLE TO DETERMINE THE FAILURE ROOT CAUSE.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED, 19 DAYS AFTER PRIMARY SURGERY, DUE TO STEM LOOSENING. THE STEM, HEAD, AND INLAY HAVE BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1213246 QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 2 HIP CEMENTLESS STEM JDI MEDACTA INTERNATIONAL SA 01.12.022 162927 07630030802034

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention