BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL KNEE HIGH ACTIVITY

    MDR report key: 5805445 · Received July 19, 2016

    Report

    Report Number
    1836248-2016-00003
    Event Type
    Injury
    Date Received
    July 19, 2016
    Date of Event
    June 6, 2016
    Report Date
    July 19, 2016
    Manufacturer
    OSSUR AMERICAS, INC.
    Product Code
    ISY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL COMPLAINT IMPLIED THE PRODUCT FAILURE WAS A CONTRIBUTOR TO THE INCIDENT. UPON FURTHER RESEARCH IT WAS DETERMINED THE PRODUCT FAILURE WAS THE RESULT OF THE PATIENT FALL AND THE PRODUCT WAS NOT A CONTRIBUTOR TO THE INCIDENT.

    Description of Event or Problem · 1

    AN AMPUTEE PATIENT WAS ASCENDING THE STAIRS WHILE CARRYING AN OBJECT AND WAS NOT USING A HANDRAIL. SHE FELL WHILE ASCENDING THE STAIRS, RESULTING IN A BROKEN BONE IN HER FOOT AND CAUSING DAMAGE TO HER PROSTHETIC KNEE.

    Description of Event or Problem · 1

    ABOVE KNEE AMPUTEE PATIENT WEARING A TOTAL KNEE PROSTHETIC FELL ON THE STAIRS IN HER HOME. AT THAT TIME, THE TOP THREADING SHEARED OFF THE KNEE. HER FALL RESULTED IN A BROKEN BONE IN HER FOOT. HER PROSTHETIST SAID SHE IS RECOVERING FROM THE FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457177 TOTAL KNEE HIGH ACTIVITY JOINT KNEE EXTERNAL LIMB PROSTHETIC ISY OSSUR AMERICAS, INC. 2100

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention