BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 5

    MDR report key: 12223761 · Received July 26, 2021

    Report

    Report Number
    3005180920-2021-00645
    Event Type
    Injury
    Date Received
    July 26, 2021
    Date of Event
    July 13, 2021
    Report Date
    July 26, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802065
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 23 JULY 2021: LOT 083652: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-FEB-2009. EXPIRATION DATE: 31/12/2013. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD. NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED ON THIS LOT SINCE 2017. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER: HIP REVISION SURGERY PERFORMED 12 YEARS AFTER CEMENTLESS THA IN (B)(6) YEAR OLD MAN. RADIOLOGIC IMAGE PROVIDED SHOWS THE PRESENCE OF BONE ALTERATIONS THAT CAN BE ASCRIBED TO AN INFECTION. INFECTION IS A KNOWN POSSIBLE ADVERSE EVENT FOLLOWING EVERY SURGERY, INCLUDING THA'S AND CAN BE HARDLY RELATED TO IMPLANT. PRELIMINARY INVESTIGATION PERFORMED BY PROJECT MANAGER: LOOKING AT THE PICTURE RECEIVED WITH THE COMPLAINT IS POSSIBLE TO SEE THE HYDROXYAPATITE HAS BEEN TOTALLY REABSORBED AS EXPECTED. NO DEFINITIVE ROOT CAUSE CAN BE DEFINED.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED 12 YEARS 2 MONTHS AFTER THE PRIMARY DUE TO STEM LOOSENING WITH SUPPOSED INFECTION. THE SURGEON DECIDED TO REMOVE ALL THE IMPLANTS AND IMPLANT A NEW HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1122210 STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 5 CEMENTLESS STEM JDI MEDACTA INTERNATIONAL SA 01.12.025 083652 07630030802065

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention