BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR EBS KNEE JOINT

    MDR report key: 6232250 · Received January 9, 2017

    Report

    Report Number
    9616494-2017-00002
    Event Type
    Malfunction
    Date Received
    January 9, 2017
    Report Date
    December 16, 2016
    Manufacturer
    OTTO BOCK HEALTHCARE GMBH
    Product Code
    ISY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT NOTIFICATION ASSOCIATED WITH THIS DEVICE DESCRIBED THAT THERE IS PLAY IN THE AXIS OF THE KNEE JOINT. NO SERIOUS INJURIES WERE SUSTAINED AS A RESULT OF THE FAILURE AND NO MEDICAL TREATMENT WAS REQUIRED. THE EVALUATION OF THIS DEVICE WAS CONDUCTED AT THE MANUFACTURER'S SERVICE CENTER ON JANUARY 9TH, 2017. AFTER EVALUATION WE CAN CONFIRM THAT ONE BOLT IN THE BACK OF THE KNEE JOINT DISENGAGED CAUSING PLAY. NO FALL OR INJURY OCCURRED DUE TO THIS FAILURE, BUT IT COULD HAVE LED TO PATIENT INJURY.

    Description of Event or Problem · 1

    KNEE JOINT WAS SENT IN FOR REPAIR. CUSTOMER STATED THAT THERE IS PLAY IN THE KNEE JOINT / AXIS. NO FALL OR INJURY OCCURRED DUE TO THIS FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18787 MODULAR EBS KNEE JOINT MODULAR EBS KNEE JOINT ISY OTTO BOCK HEALTHCARE GMBH 3R60

    Patients

    Seq Age Sex Outcome Treatment
    1