BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H CEMENTLESS STEM #3 STD

    MDR report key: 4861503 · Received June 19, 2015

    Report

    Report Number
    3005180920-2015-00127
    Event Type
    Injury
    Date Received
    June 19, 2015
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(4) 2015: LOT 132145 - (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07/18/2013. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. ON (B)(4) 2015, THE MEDICAL AFFAIRS DIRECTOR MADE THE FOLLOWING COMMENT: FEMORAL FRACTURE ON A PROBABLY WELL-FIXED FEMORAL STEM. ROOT CAUSE FOR FAILURE: TRAUMA. NO DEVICE ACTIONS RECOMMENDED.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399650 AMISTEM H CEMENTLESS STEM #3 STD CEMENTLESS FEMORAL STEM, LZO, MEH LZO

    Patients

    Seq Age Sex Outcome Treatment
    1