BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM-H PROXIMAL COATING STD STEM SIZE 2

    MDR report key: 7984653 · Received October 19, 2018

    Report

    Report Number
    3005180920-2018-00812
    Event Type
    Injury
    Date Received
    October 19, 2018
    Date of Event
    September 21, 2018
    Report Date
    October 19, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804373
    PMA / PMN Number
    K161635
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 18 OCTOBER 2018: LOT 180053: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17 MAY 2018. EXPIRATION DATE: 2023-05-08. 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

    REVISION SURGERY, 17 DAYS AFTER PRIMARY, DUE TO STEM SUBSIDENCE. THE SURGEON REMOVED THE STEM AND HEAD AND IMPLANTED ANOTHER COMPANY'S PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823733 AMISTEM-H PROXIMAL COATING STD STEM SIZE 2 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 180053 07630030804373

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention