BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR EBS KNEE JOINT

    MDR report key: 6338623 · Received February 17, 2017

    Report

    Report Number
    9616494-2017-00015
    Event Type
    Malfunction
    Date Received
    February 17, 2017
    Report Date
    February 17, 2017
    Manufacturer
    OTTO BOCK HEALTHCARE GMBH
    Product Code
    ISY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT NOTIFICATION ASSOCIATED WITH THIS DEVICE DESCRIBED THAT SCREWS BECAME LOOSE AND THE UPPER SECTION IS DISLOCATED FROM THE LOWER SECTION WHICH HAS CAUSED THE USER TO FALL. BASED ON THE INFORMATION PROVIDED 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 3RD, 2017. WE CAN CONFIRM THAT THE BOLTS IN THE POSTERIOR UPPER PART ARE LOOSE. THE FRONT FRAME IS BENT DUE TO FURTHER USAGE OF THE DEVICE WITH LOOSENED BOLTS. WE ALSO FOUND THAT THE CONNECTION ROD OF THE HYDRAULIC IS BROKEN. AN EXACT REASON FOR THE LOOSE BOLTS AND THE BROKEN CONNECTION ROD COULD NOT BE DETERMINED. THEREFORE, ADDITIONAL DATA REGARDING PATIENT AND USAGE OF THE DEVICE WERE REQUESTED. THESE DATA DID NOT PROVIDE ANY NEWS WHICH WOULD ALLOW US TO COME TO A MEANINGFUL RESULT. THE LOOSE BOLTS COULD BE THE REASON FOR THE FALL. NO 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 UPPER SCREWS HAVE LOOSENED AND THE UPPER SECTION IS DISLOCATED FROM THE LOWER SECTION WHICH HAS CAUSED THE USER TO FALL. BASED ON THE INFORMATION PROVIDED THERE WERE NO SERIOUS INJURIES SUSTAINED AS A RESULT OF THE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122575 MODULAR EBS KNEE JOINT MODULAR EBS KNEE JOINT ISY OTTO BOCK HEALTHCARE GMBH 3R60

    Patients

    Seq Age Sex Outcome Treatment
    1