BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H COATED LAT STEM SIZE 4

    MDR report key: 12687958 · Received October 25, 2021

    Report

    Report Number
    3005180920-2021-00823
    Event Type
    Injury
    Date Received
    October 25, 2021
    Date of Event
    September 23, 2021
    Report Date
    October 25, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804205
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(6) 2021: LOT 133083: 80 ITEMS MANUFACTURED AND RELEASED ON 09-OCT-2013. EXPIRATION DATE: 2018-AUG-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 74 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING PAIN DUE TO A POTTED STEM AND THE CAUSE OF THE POTTED STEM IS UNKNOWN. 7 YEARS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE STEM AND HEAD WITH COMPETITOR PRODUCTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1590901 AMISTEM H COATED LAT STEM SIZE 4 UNCEMENTED HIP STEM LZO MEDACTA INTERNATIONAL SA 01.18.144 133083 07630030804205

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention