BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H HA COATED STD STEM SIZE 2

    MDR report key: 11831979 · Received May 17, 2021

    Report

    Report Number
    3005180920-2021-00382
    Event Type
    Injury
    Date Received
    May 17, 2021
    Date of Event
    April 19, 2021
    Report Date
    May 17, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804083
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 30 APRIL 2021: LOT 130673: 60 ITEMS MANUFACTURED AND RELEASED ON 10-MAY-2013. EXPIRATION DATE: 2018-03-31. 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 SINCE 2017.

    Description of Event or Problem · 1

    7 YEARS AND 9 MONTHS THE SURGEON REVISED THE STEM DUE TO LOOSENING IN THE PROXIMAL PART. THIS PATIENT HAD INTERMEDIATE REVISION SURGERY BUT THERE IS NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733586 AMISTEM H HA COATED STD STEM SIZE 2 HIP CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 01.18.132 130673 07630030804083

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention