BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 2

    MDR report key: 8019251 · Received October 30, 2018

    Report

    Report Number
    3005180920-2018-00850
    Event Type
    Injury
    Date Received
    October 30, 2018
    Date of Event
    October 9, 2018
    Report Date
    October 31, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802140
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON 30 OCTOBER 2018 WE WERE INFORMED THAT THE SUSPECTED PE WEAR IS NOT CONFIRMED. THE EVENT DESCRIPTION IS REVISION SURGERY PERFORMED, 9 YEARS AFTER PRIMARY SURGERY, DUE TO ASEPTIC FEMORAL LOOSENING.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 30 OCTOBER 2018. LOT 081458: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10 JULY 2008. EXPIRATION DATE: 2013-05-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. OTHER DEVICE INVOLVED: LINER: CC E CC LIGHT FLAT PE LINER Ø 28 / E REFERENCE 01.26.2844STT. LOT 060220: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 APRIL 2006 . EXPIRATION DATE: 2011-02-28. 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 PERFORMED BY MEDICA AFFARIS MANAGER: HIP REVISION SURGERY OCCURRED 9 YEARS AFTER PRIMARY CEMENTLESS TOTAL HIP ARTHROPLASTY. RADIOGRAPHIC IMAGES PROVIDED SHOW THE PRESENCE OF RADIOLUCENT LINES AROUND THE STEM AND SIGNS OF STRESS SHIELDING. ASEPTIC LOOSENING IS A POSSIBLE, LITERATURE DESCRIBED ADVERSE EVENT AFTER CEMENTLESS TOTAL HIP ARTHROPLASTY AND CAUSES ARE OFTEN UNKNOWN. THE REASON OF THIS EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    ON (B)(6) 2018 WE WERE INFORMED THAT A REVISION SURGERY WILL BE PERFORMED DUE TO ASEPTIC FEMORAL LOOSENING, THE REASON IS PROBABLY PE WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860893 QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 2 CEMENTLESS HIP STEM JDI MEDACTA INTERNATIONAL SA 081458 07630030802140

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention