BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR EBS KNEE JOINT

    MDR report key: 6950820 · Received October 16, 2017

    Report

    Report Number
    9616494-2017-00047
    Event Type
    Malfunction
    Date Received
    October 16, 2017
    Report Date
    October 16, 2017
    Manufacturer
    OTTO BOCK HEALTHCARE GMBH
    Product Code
    ISY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT NOTIFICATION ASSOCIATED WITH THIS DEVICE DESCRIBED THAT THE KNEE JOINT IS NOISY. THE CUSTOMER STATED THAT THEY HEARD A CLICKING AND POPPING NOISE. THE USER DID NOT FALL, NO SERIOUS INJURIES WERE SUSTAINED AS A RESULT OF THE FAILURE AND NO MEDICAL TREATMENT WAS REQUIRED. THE EVALUATION OF THIS SPECIFIC DEVICE WAS CONDUCTED AT OUR CANADIAN AFTER SALES SERVICE CENTER ON SEPTEMBER 22ND, 2017. AFTER EVALUATION WE FOUND THAT ONE BOLT IN THE UPPER POSTERIOR SECTION OF THE KNEE JOINT WAS LOOSE. DUE TO FURTHER USAGE OF THE KNEE JOINT WITH LOOSENED BOLT THE UPPER PART OF THE KNEE JOINT WAS DAMAGED. AN EXACT REASON FOR THE LOOSENING OF THE BOLT COULD NOT BE DETERMINED. IN THIS SPECIFIC CASE THE FAILURE DID NOT LEAD TO A FALL AND/OR SERIOUS INJURY, BUT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF IT WERE TO RECUR. THEREFORE, WE REPORT THIS FAILURE ACCORDING TO GUIDANCE FOR INDUSTRY AND FDA STAFF ON "MDR FOR MANUFACTURERS" CHAPTER 2.15.

    Description of Event or Problem · 1

    KNEE JOINT WAS SENT IN FOR REPAIR. CUSTOMER STATED THAT THE KNEE JOINT IS NOISY; THEY HEARD A CLICKING AND POPPING NOISE. THE USER DID NOT FALL AND SUSTAINED NO SERIOUS INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730588 MODULAR EBS KNEE JOINT MODULAR EBS KNEE JOINT ISY OTTO BOCK HEALTHCARE GMBH 3R60

    Patients

    Seq Age Sex Outcome Treatment
    1