BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H, HA COATED STEM SIZE 2 LAT

    MDR report key: 6604410 · Received June 1, 2017

    Report

    Report Number
    3005180920-2017-00274
    Event Type
    Injury
    Date Received
    June 1, 2017
    Date of Event
    May 1, 2017
    Report Date
    June 1, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 29 MAY 2017. LOT 148445: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24 MARCH 2015. EXPIRATION DATE: 2020-02-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY WAS NECESSARY DUE TO LOOSENING OF THE AMISTEM-H. NO PIECE AVAILABLE FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386736 AMISTEM H, HA COATED STEM SIZE 2 LAT CEMENTLESS FEMORAL COMPONENT LZO MEDACTA INTERNATIONAL SA 148445

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention