BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED STD STEM SIZE 4

    MDR report key: 9876850 · Received March 25, 2020

    Report

    Report Number
    3005180920-2020-00174
    Event Type
    Injury
    Date Received
    March 25, 2020
    Date of Event
    February 25, 2020
    Report Date
    March 25, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804106
    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 BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 6 MARCH 2020: LOT 140758: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-APR-2014. EXPIRATION DATE: 2019-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR EVENTS REPORTED. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR 5 YEARS AFTER PRIMARY CEMENTLESS THA THE STEM IS REVISED DUE TO MOBILIZATION. THE LOW-QUALITY IMAGES SHOW AN OSTEOLYTIC REGION IN ZONE 6 OF UNKNOWN ORIGIN. NO COMMENTS WERE MADE TO THE STATUS OF THE ACETABULAR INSERT. SOME SIGNS OF RADIOGRAPHIC LOOSENING ARE LASO VISIBLE IN THE PROXIMAL REGION OF THE FEMUR. THE MAIN CAUSE FOR THIS LOOSENING CANNOT BE DETERMINED WITH THE INFORMATION AT HAND.

    Description of Event or Problem · 1

    LOOSENING OF AN AMISTEM-H 5 YEARS AFTER THE PRIMARY SURGERY. THE SURGEON REVISED THE STEM LINER AND HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342141 STEM: AMISTEM H HA COATED STD STEM SIZE 4 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 01.18.134 140758 07630030804106

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention