BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL CEMENTLESS STEM SIZE 6 LAT

    MDR report key: 3810220 · Received April 28, 2014

    Report

    Report Number
    3006639916-2014-00048
    Event Type
    Injury
    Date Received
    April 28, 2014
    Date of Event
    March 28, 2014
    Report Date
    April 28, 2014
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KXA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    SURGEON PROCEEDED WITH WASHING OUT THE HIP DUE TO SEVERE INFECTION AND HE WILL REVISE THE PT SHORTLY. REF MFR #3005180920-2014-00048.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253655 AMISTEM H FEMORAL CEMENTLESS STEM SIZE 6 LAT FEMORAL CEMENTLESS STEM KXA MEDACTA INTERNATIONAL SA 101026

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention MPACT SHELL: SHELL CODE 01.32.052DH, LOT #092481| LINER CODE: 01.32.3644HCT, LOT 121151