BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM-H PROXIMAL COATING STD STEM SIZE 3

    MDR report key: 8361561 · Received February 22, 2019

    Report

    Report Number
    3005180920-2019-00090
    Event Type
    Injury
    Date Received
    February 22, 2019
    Date of Event
    January 24, 2019
    Report Date
    February 22, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804380
    PMA / PMN Number
    K161635
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR. FEMORAL COMPONENT REVISION SURGERY IN A (B)(6) YEAR PATIENT. IN THE RADIOGRAPHIC IMAGES PROVIDED, REGIONS OF OSTEOLYSIS AND BONE ALTERATIONS ARE VISIBLE. NO INFORMATION ON THE TIME OF PRIMARY SURGERY, PATIENT GENERAL HEALTH OR COMORBIDITIES IS AVAILABLE. ON THE BASIS OF AVAILABLE INFORMATION, NO FINAL CONCLUSION CAN BE DRAWN. BATCH REVIEW PERFORMED ON 22 FEBRUARY 2019: LOT 182814: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 JUNE 2018. EXPIRATION DATE: 2023-06-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED DUE TO STEM LOOSENING. DATE OF PRIMARY SURGERY AND DETAILS ABOUT THE BALL HEAD ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156733 AMISTEM-H PROXIMAL COATING STD STEM SIZE 3 HIP STEM LZO MEDACTA INTERNATIONAL SA 182814 07630030804380

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention