BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 2

    MDR report key: 9401757 · Received December 3, 2019

    Report

    Report Number
    3005180920-2019-01012
    Event Type
    Injury
    Date Received
    December 3, 2019
    Date of Event
    November 6, 2019
    Report Date
    December 2, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802140
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 07 NOVEMBER 2019. LOT 083625/T: 1 ITEM MANUFACTURED AND RELEASED ON 19-MAY-2014. EXPIRATION DATE: 2019-04-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 1 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: 5 YEARS AFTER PRIMARY CEMENTLESS THA THE FEMORAL STEM GETS LOOSE AND NEEDS REVISION. WE HAVE ONLY ONE, POOR-QUALITY IMAGE: IN THIS SINGLE PROJECTION THE STEM LOOKS SLIGHTLY UNDERSIZED, BUT OF COURSE IT'S POSSIBLE THAT IN THE PERPENDICULAR VIEW THE STABILITY THAT ALLOWED IT TO PERFORM FOR 5 YEARS IS EVIDENT. APART FROM THIS, WE ARE UNABLE TO IDENTIFY A POTENTIAL CAUSE FOR THIS LOOSENING.

    Description of Event or Problem · 1

    PATIENT REQUIRED REVISION DUE TO THIGH PAIN (STEM LOOSENING) ALMOST 5 YEARS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1197668 STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 2 CEMENTLESS STEM JDI MEDACTA INTERNATIONAL SA 083625/T 07630030802140

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention