BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM-P STD STEM SIZE 7

    MDR report key: 8319912 · Received February 8, 2019

    Report

    Report Number
    3005180920-2019-00045
    Event Type
    Injury
    Date Received
    February 8, 2019
    Date of Event
    January 11, 2019
    Report Date
    February 8, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720069
    PMA / PMN Number
    K173794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 05 FEBRUARY 2019 LOT 182535: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29 AUGUST 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 WITHOUT ANY SIMILAR REPORTED EVENT. 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

    BONE FRACTURE OCCURRED DURING STEM IMPLANTATION, IT WAS BROACHED TO A AMIS 7 AND IMPLANTED A COLLARLESS 7 AMISTEM-P. THE SURGEON CABLED THE FRACTURE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113758 AMISTEM-P STD STEM SIZE 7 HIP STEM LZO MEDACTA INTERNATIONAL SA 182535 07630040720069

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention