BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR EBS KNEE JOINT

    MDR report key: 6352216 · Received February 23, 2017

    Report

    Report Number
    9616494-2017-00016
    Event Type
    Malfunction
    Date Received
    February 23, 2017
    Report Date
    February 22, 2017
    Manufacturer
    OTTO BOCK HEALTHCARE GMBH
    Product Code
    ISY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT NOTIFICATION ASSOCIATED WITH THIS DEVICE DESCRIBED THAT USER FELT PLAY IN THE AXIS OF THE KNEE JOINT. BASED ON THE INFORMATION PROVIDED, THE USER DID NOT FALL AND THERE WERE NO SERIOUS INJURIES SUSTAINED AS A RESULT OF THE FAILURE. THE EVALUATION OF THIS SPECIFIC DEVICE WAS CONDUCTED AT THE MANUFACTURER'S SERVICE CENTER ON FEBRUARY 16TH, 2017. WE CAN CONFIRM THAT THE BOLTS IN THE POSTERIOR UPPER PART ARE LOOSE. AN EXACT REASON FOR THE LOOSE BOLTS COULD NOT BE DETERMINED. THE FRONT FRAME IS BENT DUE TO FURTHER USAGE OF THE DEVICE WITH LOOSENED BOLTS. NO FALL OR SERIOUS INJURY OCCURRED DUE TO THIS FAILURE, BUT IT COULD HAVE LED TO PATIENT INJURY IF THE MALFUNCTION WERE TO RECUR.

    Description of Event or Problem · 1

    KNEE JOINT WAS SENT IN FOR REPAIR. CUSTOMER STATED THAT THE USER FELT PLAY IN THE AXIS OF THE KNEE JOINT. BASED ON THE INFORMATION PROVIDED, THE USER DID NOT FALL AND THERE WERE NO SERIOUS INJURIES SUSTAINED AS A RESULT OF THE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136497 MODULAR EBS KNEE JOINT MODULAR EBS KNEE JOINT ISY OTTO BOCK HEALTHCARE GMBH 3R60-PRO

    Patients

    Seq Age Sex Outcome Treatment
    1