BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL CEMENTLESS STEM SIZE 4 STD

    MDR report key: 3599107 · Received January 13, 2014

    Report

    Report Number
    3005180920-2013-00188
    Event Type
    Injury
    Date Received
    January 13, 2014
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW: AMISTEM H CEMENTLESS STEM SIZE 4 STANDARD: REF. 01.18.134 / LOT 132147 ((B)(4) STEMS PRODUCED). ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MFG. THE (B)(4) STEMS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD AND ONLY ONE SIMILAR INCIDENT WAS REPORTED WITH MDR 2013-00136. FROM THE DATA COLLECTED, THERE ARE NO EVIDENCE THAT THE EVENT IS DEVICE RELATED.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28478 AMISTEM H FEMORAL CEMENTLESS STEM SIZE 4 STD FEMORAL CEMENTLESS STEM LZO MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1