BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR EBS KNEE JOINT

    MDR report key: 6296218 · Received February 2, 2017

    Report

    Report Number
    9616494-2017-00011
    Event Type
    Malfunction
    Date Received
    February 2, 2017
    Report Date
    January 3, 2017
    Manufacturer
    OTTO BOCK HEALTHCARE GMBH
    Product Code
    ISY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT NOTIFICATION ASSOCIATED WITH THIS DEVICE DESCRIBED THAT THE USER WAS WALKING UP A HILL WHEN THE SCREWS CAME LOOSE. THE CUSTOMER REPORTED THAT THE USER FELL. THE USER WAS NOT INJURED DURING FALL, NO MEDICAL TREATMENT WAS REQUIRED. THE EVALUATION OF THIS DEVICE WAS CONDUCTED AT THE MANUFACTURER'S SERVICE CENTER ON JANUARY 23RD, 2017. WE CAN CONFIRM THAT TWO BOLTS IN THE POSTERIOR UPPER PART ARE LOST AND BOTH HYDRAULICS ARE DAMAGED. AN EXACT REASON FOR THAT COULD NOT BE DETERMINED. PATIENT FELL DUE TO THIS FAILURE, BUT WAS NOT INJURED.

    Description of Event or Problem · 1

    KNEE JOINT WAS SENT IN FOR REPAIR. CUSTOMER STATED THAT THE USER WAS WALKING UP A HILL WHEN THE SCREWS CAME LOOSE. THEY REPORTED THAT THE USER FELL. THE USER WAS NOT INJURED DURING FALL, AND NO MEDICAL TREATMENT WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80071 MODULAR EBS KNEE JOINT MODULAR EBS KNEE JOINT ISY OTTO BOCK HEALTHCARE GMBH 3R60

    Patients

    Seq Age Sex Outcome Treatment
    1