BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM COLLARED HA COATED LAT STEM SIZE 4

    MDR report key: 9416216 · Received December 5, 2019

    Report

    Report Number
    3005180920-2019-01043
    Event Type
    Injury
    Date Received
    December 5, 2019
    Date of Event
    November 13, 2019
    Report Date
    May 12, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804694
    PMA / PMN Number
    K121011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 19 NOVEMBER 2019: LOT 133966: 25 ITEMS MANUFACTURED AND RELEASED ON 28-OCT-2013. EXPIRATION DATE: 2018-09-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 23 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF INSTABILITY WHICH WAS CAUSED FROM A LOOSE STEM. THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD, AND LINER ALMOST 4 YEARS AND 8 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1209825 STEM: AMISTEM COLLARED HA COATED LAT STEM SIZE 4 UNCEMENTED HIP STEM LZO MEDACTA INTERNATIONAL SA 133966 07630030804694

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention