BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL CEMENTLESS STEM SIZE 4 STD

    MDR report key: 3546279 · Received November 20, 2013

    Report

    Report Number
    3005180920-2013-00143
    Event Type
    Injury
    Date Received
    November 20, 2013
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: AMISTEM H CEMENTLESS FEMORAL STEM SIZE 4 STD: REF. (B)(4) / LOT 131159 ((B)(4) STEMS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MFG, INCLUDING WASHING AND STERILIZATION PROCEDURES. THE (B)(4) STEMS BELONGING TO THIS LOT HAVE ALREADY SOLD W/O ANY OTHER SIMILAR INCIDENT. FROM THE DATA COLLECTED, THERE ARE NO EVIDENCE THAT THE EVENT IS DEVICE RELATED.

    Description of Event or Problem · 1

    REF IMP REPORT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602721 AMISTEM H FEMORAL CEMENTLESS STEM SIZE 4 STD FEMORAL CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA

    Patients

    Seq Age Sex Outcome Treatment
    1