BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 10725241 · Received October 23, 2020

    Report

    Report Number
    3005180920-2020-00725
    Event Type
    Injury
    Date Received
    October 23, 2020
    Date of Event
    October 6, 2020
    Report Date
    October 23, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802034
    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 05 OCTOBER 2020: LOT 091043: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-JUNE-2009. EXPIRATION DATE: 2014-04-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 01-JAN-2016. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: HIP REVISION SURGERY PERFORMED 10 YEARS AFTER CEMENTLESS TOTAL HIP ARTHROPLASTY IN A (B)(6) YEAR OLD WOMAN. ACCORDING TO THE REPORT, THE REASON OF STEM REMOVAL IS IMPINGEMENT WITH THE ACETABULAR COMPONENT. RADIOGRAPHIC IMAGES PROVIDED SHOW THE PRESENCE OF SUBOPTIMAL ACETABULAR COMPONENT POSITION. WE CANNOT TELL IF THIS WAS THE INITIAL POSITION OR THE RESULT OF CUP MIGRATION. THIS HAS PROBABLY CAUSED ABNORMAL WEAR OF THE ACETABULAR INSERT THAT RESULTED IN EXTENSIVE OSTEOLYTIC DAMAGE TO THE FEMORAL BONE, CAUSING LOOSENING OF THE STEM. THE REASON OF STEM REMOVAL IS HARDLY RELATED TO AN IMPLANT MALFUNCTION.

    Description of Event or Problem · 1

    REVISION SURGERY 9 YEARS AND 11 MONTHS AFTER PRIMARY SURGERY FOR IMPINGEMENT OF MEDACTA DEVICES WITH THE ACETABULAR SHELL OF COMPETITOR. THE SURGEON REVISED SUCCESSFULLY THE MEDACTA STEM AND HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1193059 STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 2 CEMETLESS HIP STEM JDI MEDACTA INTERNATIONAL SA 01.12.022 091043 07630030802034

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention