BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM P AMISTEM-P STD STEM SIZE 7

    MDR report key: 8408124 · Received March 11, 2019

    Report

    Report Number
    3005180920-2019-00139
    Event Type
    Injury
    Date Received
    March 11, 2019
    Date of Event
    February 10, 2019
    Report Date
    March 11, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720069
    PMA / PMN Number
    K173794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 11 MARCH 2019. LOT 182535: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-AUG-2018. EXPIRATION DATE: 2023-08-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ANOTHER SIMILAR REPORTED EVENT [COMPLAINT (B)(4) (MDR 2019-00045)]. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER: INTRAOPERATIVE FEMORAL FRACTURES ARE KNOWN POSSIBLE ADVERSE EVENTS OF TOTAL HIP REPLACEMENTS, DESCRIBED AND QUANTIFIED IN LITERATURE. THEY MAINLY DEPEND ON BONE MORPHOLOGY AND MECHANICAL PROPERTIES. IN THIS CASE, THERE IS NO REASON TO SUSPECT A MALFUNCTIONING DEVICE.

    Description of Event or Problem · 1

    RIGHT AFTER THE PRIMARY SURGERY THE PATIENT CONTINUED TO COMPLAIN OF PAIN. THE SURGEON PERFORMED A POST OP X-RAY AND FOUND THAT THE FEMUR WAS FRACTURED. THE SURGEON THEN, ON THE SAME DAY, PERFORMED A REVISION TO REPLACE THE HEAD, STEM AND THEN CABLED THE FRACTURE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200733 STEM: AMISTEM P AMISTEM-P STD STEM SIZE 7 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 182535 07630040720069

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention