BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA-S CEMENTLESS, SAND BLASTED STD STEM SIZE 4

    MDR report key: 11331085 · Received February 16, 2021

    Report

    Report Number
    3005180920-2021-00121
    Event Type
    Injury
    Date Received
    February 16, 2021
    Date of Event
    January 18, 2021
    Report Date
    February 16, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030801853
    PMA / PMN Number
    K072857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 15.FEB.2021: LOT 083861: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 3-FEB-2009. EXPIRATION DATE: 2013-12-31. 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

    REVISION SURGERY 11 YEARS AND 8 MONTHS AFTER THE PRIMARY SURGERY FOR PAIN DUE TO A LOOSE STEM. THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD, AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232034 QUADRA-S CEMENTLESS, SAND BLASTED STD STEM SIZE 4 HIP UNCEMENTED STEM JDI MEDACTA INTERNATIONAL SA 01.12.004 083861 07630030801853

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention