BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM P STD STEM SIZE 6

    MDR report key: 9283658 · Received November 6, 2019

    Report

    Report Number
    3005180920-2019-00945
    Event Type
    Injury
    Date Received
    November 6, 2019
    Date of Event
    October 11, 2019
    Report Date
    November 6, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720052
    PMA / PMN Number
    K173794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 23 OCTOBER 2019. LOT 1810242: 70 ITEMS MANUFACTURED AND RELEASED ON 22-MAR-2019. EXPIRATION DATE: 2024-03-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 39 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED 4 MONTHS AFTER THE PRIMARY DUE TO INSTABILITY DUE TO A SLIGHTLY SUBSIDED STEM. THE SURGEON REVISED THE 28 MM COCR HEAD M WITH A 28 MM COCR HEAD XXL AND REVISED THE VERSAFITCUP DM LINER HC 58/28 WITH A VERSAFITCUP DM LINER HC 58/28. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1083036 STEM: AMISTEM P STD STEM SIZE 6 CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 1810242 07630040720052

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention