BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED STD STEM SIZE 2

    MDR report key: 9393529 · Received December 2, 2019

    Report

    Report Number
    3005180920-2019-01017
    Event Type
    Injury
    Date Received
    December 2, 2019
    Date of Event
    November 5, 2019
    Report Date
    December 2, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804083
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 11 NOVEMBER 2019. LOT 161928: 30 ITEMS MANUFACTURED AND RELEASED ON 20-JUN-2016. EXPIRATION DATE: 2021-06-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 30 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER. HIP REVISION SURGERY PERFORMED 3 YEARS AFTER CEMENTLESS TOTAL HIP ARTHROPLASTY IN A YOUNG (51 YEAR OLD) WOMAN. RADIOGRAPHIC IMAGES PROVIDED SHOW THE PRESENCE OF RADIOLUCENT LINES IN PROXIAML FEMORAL GRUEN ZONES AND THE STEM LOOKS SLIGHTLY UNDER SIZED. THE REASON OF THIS CHOICE IS UNKNOWN: BONE MORPHOLOGY OR PATIENT ANATOMY MAY BE ONE REASON BUT THIS CANNOT BE CONFIRMED NOT HAVING PREOPERATIVE IMAGES. 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

    REVISION SURGERY PERFORMED, 3 YEARS AFTER PRIMARY SURGERY, DUE TO STEM LOOSENING. DURING THE REVISION SURGERY, THE SURGEON REPORTED THAT THE REASON FOR THE REVISION SURGERY IS UNDER SIZING OF THE STEM AND VARUS IMPLANTATION OF THE AMISTEM. STEM, HEAD AND INLAY HAVE BEEN REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1187537 STEM: AMISTEM H HA COATED STD STEM SIZE 2 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 161928 07630030804083

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention