BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM-H PROXIMAL COATING STD STEM SIZE 3

    MDR report key: 10486940 · Received September 3, 2020

    Report

    Report Number
    3005180920-2020-00574
    Event Type
    Injury
    Date Received
    September 3, 2020
    Report Date
    September 3, 2020
    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

    BATCH REVIEW PERFORMED ON (B)(6) 2020: LOT 171661: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-JUL-2017. EXPIRATION DATE: 2022-06-19. 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

    ABOUT 1 YEAR AFTER PRIMARY SURGERY THE PATIENT STEM WAS REVISED FOR LOOSENING. THIS IS THE THIRD REVISION REPORTED ON THIS PATIENT FOR DIFFERENT REASONS SINCE THE PRIMARY SURGERY. THE CORRECT DATE AND LOCATION FOR THE FIRST REVISION IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    955556 AMISTEM-H PROXIMAL COATING STD STEM SIZE 3 HIP UNCEMENTED FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 01.18.173 171661 07630030804380

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention