BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 0, SHORT NECK

    MDR report key: 9510765 · Received December 23, 2019

    Report

    Report Number
    3005180920-2019-01101
    Event Type
    Injury
    Date Received
    December 23, 2019
    Date of Event
    December 3, 2019
    Report Date
    December 23, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802607
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 13 DECEMBER 2019: LOT 163270: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 5 JULY 2016. EXPIRATION DATE: 2021-06-21. 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. CLINICAL EVALUATION: 3 YEARS AFTER PRIMARY CEMENTLESS THA THE STEM IS FOUND LOOSE AND REPLACED. THE DOCUMENTATION SUPPLIED DOES NOT REPRESENT THE PRE-REVISION SITUATION, HENCE NO ASSESSMENT OF THIS CASE CAN BE PERFORMED WITH THE INFORMATION AT HAND. ASEPTIC LOOSENING OF PROSTHETIC COMPONENTS IS A POSSIBLE ADVERSE EVENT FOLLOWING THA, DESCRIBED IN LITERATURE; CAUSES OFTEN REMAIN UNDETERMINED.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED 3 YEARS AND 1 MONTH AFTER THE PRIMARY DUE TO INSTABILITY CAUSED BY A LOOSE STEM. THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1303788 STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 0, SHORT NECK HIP SEMENTLESS STEM JDI MEDACTA INTERNATIONAL SA 163270 07630030802607

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention