BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENIUM - BIONIC PROSTHETIC SYSTEM

    MDR report key: 10356505 · Received August 3, 2020

    Report

    Report Number
    9615892-2020-00006
    Event Type
    Injury
    Date Received
    August 3, 2020
    Date of Event
    July 18, 2020
    Report Date
    July 24, 2020
    Manufacturer
    OTTO BOCK HEALTHCARE PRODUCTS GMBH
    Product Code
    ISY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION AND INVESTIGATION OF THE DEVICE SHOWED NO RELEVANT ERROR WHICH MAY HAVE CAUSED OR CONTRIBUTED TO THE OCCURRED EVENT.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION IN PROGRESS; SUPPLEMENTAL REPORT WILL BE SUBMITTED AFTER ADDITIONAL INFORMATION HAS BEEN OBTAINED.

    Description of Event or Problem · 1

    FALL - THE PATIENT WAS TAKEN TO THE HOSPITAL IMMEDIATELY AFTER THE FALL. PATIENT WAS CYCLING ON (B)(6) 2020, AT THE FIRST BREAK IT WAS NOT POSSIBLE TO SWITCH FROM BIKE MODE TO WALKING MODE, NEITHER BY APP NOR WITH THE DEVICE ITSELF. SO THE USER DROVE BACK HOME TO CONNECT THE DEVICE TO THE POWER, AFTER WHICH THE WALKING MODE WAS USABLE AGAIN. THE COCKPIT APP WAS ALSO DELETED AND REINSTALLED AT THE SAME TIME. AFTER THAT, SWITCHING FROM BIKE TO WALKING MODE WAS POSSIBLE WITHOUT ANY PROBLEMS, SEVERAL ATTEMPTS WERE MADE TO REPLICATE THE FAILURE. THE USER DROVE APPROX. 1KM, STOPPED, GOT OFF AND SWITCHED TO WALKING MODE VIA THE COCKPIT APP, THE CHANGE WAS CONFIRMED BY SIGNALS, THE USER TOOK THE FIRST STEP, THE JOINT COLLAPSED WITHOUT RESISTANCE AND RESULTS IN A FALL. FRACTURE AROUND THE ENDOPROSTHETIC FEMORAL STEM, THE FEMORAL STEM IS NOTICEABLY MOVABLE - SURGERY IS IN PREPARATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819629 GENIUM - BIONIC PROSTHETIC SYSTEM EXTERNAL ABOVE KNEE PROSTHESIS ISY OTTO BOCK HEALTHCARE PRODUCTS GMBH 3B1

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R