BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED STD STEM SIZE 2

    MDR report key: 16032688 · Received December 22, 2022

    Report

    Report Number
    3005180920-2022-00918
    Event Type
    Injury
    Date Received
    December 22, 2022
    Date of Event
    December 1, 2022
    Report Date
    December 22, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804083
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2022: LOT 160734: 100 ITEMS MANUFACTURED AND RELEASED ON 18-MAY-2016. EXPIRATION DATE: 2021-05-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    REVISION SURGERY FOR STEM LOOSENING AT ABOUT 6 YEARS AND 4 MONTHS POST-PRIMARY. THE SURGERY WAS COMPLERTED SUCCESSFULLY, STEM, HEAD AND LINER REVISED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1407401 STEM: AMISTEM H HA COATED STD STEM SIZE 2 HIP CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 01.18.132 160734 07630030804083

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention