BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMIS MOBILE LEG POSITIONER 2.0 FRAME

    MDR report key: 18018919 · Received October 27, 2023

    Report

    Report Number
    3005180920-2023-00817
    Event Type
    Malfunction
    Date Received
    October 27, 2023
    Date of Event
    August 22, 2023
    Report Date
    October 27, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    FWX
    UDI-DI
    07630040735773
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2023. LOT 1656238: 15 ITEMS MANUFACTURED AND RELEASED ON 08-MARCH-2018. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED ON THE SAME LOT.

    Description of Event or Problem · 0

    THE PROXIMAL FEMUR FRACTURE OCCURRED DURING THE SURGERY WITH THE AMIS LEG POSITIONER UPON TRIAL REDUCTION (INTERNAL ROTATION OF THE FOOT). THE SURGEON CABLED THE FRACTURE AND THE SURGERY WAS COMPLETED SUCCESSFULLY. SURGEON SAYS IT WAS THE PRESENCE OF OSTEOPHYTES THAT COULD CAUSED THE FRACTURE AND HALF THE MEDIAL CALCAR CAME OFF DURING PREPARATION AND REMOVAL OF FEMORAL BONE HEAD THAT GREATLY WEAKENED THE INTEGRITY OF THE PROXIMAL FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1690246 AMIS MOBILE LEG POSITIONER 2.0 FRAME HIP INSTRUMENT FWX MEDACTA INTERNATIONAL SA 1656238 07630040735773

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other