BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMIS 01.15.10.0321 AMIS SOCK SINGLE USE

    MDR report key: 12874314 · Received November 25, 2021

    Report

    Report Number
    3005180920-2021-00936
    Event Type
    Injury
    Date Received
    November 25, 2021
    Date of Event
    November 3, 2021
    Report Date
    November 25, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    UDI-DI
    07630040728027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 23-NOV-2021. AMIS 01.15.10.0315 AMIS SHOE LOT 1951510: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-MAY-2020. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ANOTHER SIMILAR EVENT HAS BEEN REPORTED ON THE SAME LOT.

    Description of Event or Problem · 0

    A FIBULA BONE FRACTURE HAS BEEN DISCOVERED IN A PATIENT OPERATED WITH THE AMIS LEG POSITIONER. IT IS UNKNOWN IF THE FRACTURE HAPPENED DURING THE SURGERY, IT WAS DISCOVERED DURING THE RECOVERY PERIOD. THE PATIENT HAS NOW A SPLINT TO HOLD THE FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1773618 AMIS 01.15.10.0321 AMIS SOCK SINGLE USE INSTRUMENT FOR HIP SURGERY LXH MEDACTA INTERNATIONAL SA 01.15.10.0321 07630040728027

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other