BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAUCH KNEE

    MDR report key: 7231555 · Received January 31, 2018

    Report

    Report Number
    1836248-2018-00001
    Event Type
    Injury
    Date Received
    January 31, 2018
    Report Date
    January 31, 2018
    Manufacturer
    OSSUR AMERICAS, INC.
    Product Code
    ISY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WE RECEIVED A COMPLAINT OF AN ABOVE KNEE AMPUTEE PATIENT WHO FELL WHILE WEARING A MAUCH KNEE AND SUSTAINED A FRACTURED HIP. NO FURTHER DETAILS PROVIDED AT THIS TIME.

    Description of Event or Problem · 1

    WE RECEIVED A COMPLAINT OF AN ABOVE KNEE AMPUTEE PATIENT WHO FELL WHILE WEARING A MAUCH KNEE AND SUSTAINED A FRACTURED HIP. NO FURTHER DETAILS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73913 MAUCH KNEE JOINT KNEE EXTERNAL LIMB COMPONENT ISY OSSUR AMERICAS, INC. MKN71360

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R