BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 3

    MDR report key: 11129987 · Received January 7, 2021

    Report

    Report Number
    3005180920-2021-00019
    Event Type
    Injury
    Date Received
    January 7, 2021
    Date of Event
    December 10, 2020
    Report Date
    January 7, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802157
    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 (B)(6) 2020: LOT 161558: 40 ITEMS MANUFACTURED AND RELEASED ON 20-MAY-2016. EXPIRATION DATE: 2021-05-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 37 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. PRELIMINARY INVESTIGATION PERFORMED ON (B)(6) 2020 BY MEDACTA R&D HIP PROJECT MANAGER: FROM THE RECEIVED IMAGES IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT. IT MAY BE POSSIBLE THE PRESENCE OF RADIOLUCENCIES AROUND THE STEM IN THE X-RAY IMAGE, WHILE THE EXPLANTED STEM DID NOT SHOW ANY PARTICULAR SIGN. A MORE DETAILED ANALYSIS CAN BE DONE WITH THE PHYSICAL PIECE. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER: FEMORAL COMPONENT REVISION PERFORMED 4 YEARS AFTER PRIMARY CEMENTLESS TOTAL HIP ARTHROPLASTY IN (B)(6) YEAR OLD MAN. NO INFORMATION CONCERNING PATIENT GENERAL HEALTH STATUS AND THE PRESENCE OF COMORBIDITIES IS AVAILABLE. IN THE RADIOGRAPHIC IMAGE PROVIDED, RADIOLUCENT LINES AND SIGNS OF STRESS SHIELDING ARE VISIBLE. ASEPTIC LOOSENING IS A POSSIBLE LITERATURE DESCRIBED ADVERSE EVENT AFTER PRIMARY CEMENTLESS HIP ARTHROPLASTIES AND CAUSES ARE OFTEN UNKNOWN. THE REASON OF THIS FAILURE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    REVISION SURGERY 4 YEARS AND 3 MONTHS AFTER PRIMARY FOR STEM LOOSENING. QUADRA H REPLACED WITH QUADRA C. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27859 STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 3 CEMENTLESS HIP STEM JDI MEDACTA INTERNATIONAL SA 01.12.033 161558 07630030802157

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention