BEUDAMED
    FDA Adverse Event Summary report: N

    AMISTEM H FEMORAL CEMENTLESS STEM SIZW 4 LAT

    MDR report key: 3242423 · Received July 18, 2013

    Report

    Report Number
    3006639916-2013-00085
    Date Received
    July 18, 2013
    Date of Event
    June 20, 2013
    Report Date
    July 18, 2013
    Manufacturer
    MEDACTA USA INC.
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO INFECTION (B)(6) 9 MONTHS POST PRIMARY SURGERY. THE STEM AMISTEM H WAS NOT OSSEOINTEGRATED DUE TO INFECTION AND WAS REPLACED WITH A CEMENTED STEM (AMISTEM C). REF MFR NUMBER: 30051809202013-00085.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335531 AMISTEM H FEMORAL CEMENTLESS STEM SIZW 4 LAT FEMORAL CEMENTLESS STEM LZO MEDACTA USA INC. 104019

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention CERAMIC HEAD NOT IN THE USA| LOT 122080| VERSAFITCUP CC TRIO: LINER 01.26.3248HCT| SHELL 01.26.45.0056, LOT121427