BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL CEMENTLESS STEM SIZE 5 STD

    MDR report key: 4195553 · Received October 10, 2014

    Report

    Report Number
    3005180920-2014-00132
    Event Type
    Injury
    Date Received
    October 10, 2014
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: AMISTEM H CEMENTLESS FEMORAL STEM SIZE 5 STD: REF. 01.18.135 . LOT 143134 ((B)(4) STEMS PRODUCED / (B)(4) SOLD): NO ANOMALIES FOUND RELATED TO THE PROBLEM HAPPENED. FROM THE DATA COLLECTED, THERE ARE NO EVIDENCES THAT THE EVENT IS DEVICE RELATED.

    Description of Event or Problem · 1

    IMP REF #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642770 AMISTEM H FEMORAL CEMENTLESS STEM SIZE 5 STD FEMORAL CEMENTLESS STEM LZO

    Patients

    Seq Age Sex Outcome Treatment
    1