BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H CEMENTLESS STEM #5 STD

    MDR report key: 4586337 · Received March 6, 2015

    Report

    Report Number
    3005180920-2015-00023
    Event Type
    Injury
    Date Received
    March 6, 2015
    Product Code
    MEH
    PMA / PMN Number
    K093944
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 03/06/2015: LOT 145415 - (B)(4) STEMS PRODUCED AND RELEASED ON 10/13/2014. NO ANOMALIES FOUND. TO DATE, (B)(4) STEMS OF THAT LOT HAVE BEEN SOLD WITHOUT ANY OTHER SIMILAR EVENT. ON 03/06/2015, WE RECEIVED THE CONFIRMATION THAT THE IMPLANT WILL NOT BE RECEIVED BACK. ON 03/06/2015, THE MEDICAL AFFAIRS DIRECTOR MADE THE FOLLOWING EVAL, BASED ON THE X-RAYS RECEIVED: " I DO NOT HAVE A GOOD ENOUGH DESCRIPTION OF THE EVENT. CAN I ASSUME IT WAS A TRAUMA THAT HAPPENED TO THE PT AT SOME STAGE AFTER THE FIRST OPERATION? ALSO, FROM THE PICTURES IT IS RATHER DIFFICULT TO ANALYZE THE SHAPE OF THE FRACTURE. WITH SOME ASSUMPTIONS, I CAN ASSUME THAT THIS WAS A PERIPROSTHETIC FRACTURE, POSSIBLY ORIGINATING FROM A TRAUMATIC EVENT. I HAVE NO REPORTS INDICATING IMPLANT FAILURE. THEREFORE, IF IT WAS A TRAUMA AND CONSEQUENT FEMORAL FRACTURE THAT REQUIRED A REOPERATION TO BE STABILIZED, THERE IS NO IMPLICATION OF OUR IMPLANTS."

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156456 AMISTEM H CEMENTLESS STEM #5 STD CEMENTLESS FEMORAL STEM, MEH, LZO MEH

    Patients

    Seq Age Sex Outcome Treatment
    1