BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED LAT STEM SIZE 0

    MDR report key: 9150283 · Received October 3, 2019

    Report

    Report Number
    3005180920-2019-00830
    Event Type
    Injury
    Date Received
    October 3, 2019
    Date of Event
    September 3, 2019
    Report Date
    October 3, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804168
    PMA / PMN Number
    K121011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(6) 2019: LOT 182779: (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2015. EXPIRATION DATE: 2020-10-21. 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

    THE PATIENT HAD A THA ON THE (B)(6) 2019. ON THE (B)(6) 2019 THE SURGEON DISCOVERED A PERI-PROSTHETIC FEMUR FRACTURE. ON THE (B)(6) 2019 THE PATIENT WAS OPERATED TO FIX THE FRACTURE WITH A PLATE AND CABLES. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948001 STEM: AMISTEM H HA COATED LAT STEM SIZE 0 HIP CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 182779 07630030804168

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention