BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 7

    MDR report key: 11419746 · Received March 5, 2021

    Report

    Report Number
    3005180920-2021-00174
    Event Type
    Injury
    Date Received
    March 5, 2021
    Date of Event
    February 5, 2021
    Report Date
    March 5, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802089
    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 FEBRUARY 2021: LOT 170876: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-JUL-2017. EXPIRATION DATE: 2022-07-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. PRELIMINARY INVESTIGATION PERFORMED BY MEDACTA R&D HIP PROJECT MANAGER: LOOKING AT THE IMAGE ATTACHED TO THE COMPLAINT IS VISIBLE THAT THE HA COATING AS BEEN ABSORBED BY THE PATIENT BONE AS EXPECTED. INDEED THE SURGERY WAS 4 HOURS LONG TO REMOVE THE STEM TO THE BONE, MEANING THAT IT WAS VERY WELL OSTEROINTEGRATED. A SCRATCH IS VISIBLE ON THE STEM TIP PROBABLY CAUSED DURING THE REVISION SURGERY. IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE RADIOLUCENCY LINES CAUSED OF THIS COMPLAINT. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS DIRECTOR: HIP REVISION SURGERY PERFORMED 2 YEARS AND 7 MONTHS AFTER CEMENTLESS TOTAL HIP ARTHROPLASTY IN A YOUNG MAN ((B)(6) YEAR OLD). RADIOGRAPHIC IMAGE SHOWS THE PRESENCE OF MINIMAL RADIOLUCENT LINES IN GRUEN ZONE 1, NO PAIN WAS REPORTED. IN SOME CASES, MINIMAL RADIOLUCENCIES ARE SEEN AFTER CEMENTLESS TOTAL HIP ARTHROPLASTY BUT THIS FINDING ALONE MAY NOT BE RELATED TO IMPLANT LOOSENING. IT IS A SURGEON CHOICE TO REMOVE THE IMPLANT. DURING REVISION SURGERY, THE STEM WAS DIFFICULT TO REMOVE SUGGESTING THAT SOME SORT OF FIXATION OCCURRED. THE REASON OF THIS EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED DUE TO SUBCLINICAL STEM MOBILIZATION 2 YEARS AND 7 MONTHS AFTER THE PRIMARY SURGERY. MINIMAL RADIOLUCENT LINES WERE VISIBLE ON THE X-RAY. THE STEM AND THE CUP WERE REVISED. THERE WAS NO PROBLEM WITH THE CUP, IT WAS REVISED BECAUSE THE SURGEON DIDN'T LIKE THE X-RAY WITH THE SCREWS WHICH WERE FIXING THE CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318096 QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 7 CEMENTLESS HIP STEM JDI MEDACTA INTERNATIONAL SA 01.12.027 170876 07630030802089

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention