BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR EBS KNEE JOINT

    MDR report key: 6310538 · Received February 8, 2017

    Report

    Report Number
    9616494-2017-00012
    Event Type
    Malfunction
    Date Received
    February 8, 2017
    Report Date
    January 12, 2017
    Manufacturer
    OTTO BOCK HEALTHCARE GMBH
    Product Code
    ISY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT NOTIFICATION ASSOCIATED WITH THIS DEVICE DESCRIBED THAT THE PROXIMAL HINGE OF THE KNEE JOINT BROKE AND A SCREW WAS MISSING. THE EVALUATION OF THIS SPECIFIC DEVICE WAS CONDUCTED AT THE MANUFACTURER'S SERVICE CENTER ON FEBRUARY 6TH, 2017. WE CAN CONFIRM THAT ONE BOLT IN THE POSTERIOR UPPER PART IS LOST. FURTHER USAGE OF THE KNEE JOINT WITH LOST BOLT LED TO DAMAGES AT FRONT AND REAR FRAME. THE LINKAGE (CUSTOMER SAYS HINGE) TOUCHES THE LOWER PART OF THE JOINT, BUT IT IS NOT BROKEN. AN EXACT REASON FOR THE LOST BOLT COULD NOT BE DETERMINED. 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 PROXIMAL HINGE OF THE KNEE JOINT WAS BROKEN AND A SCREW IS MISSING. THE PATIENT DID NOT FALL, NO SERIOUS INJURY OCCURRED DUE TO THIS FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95238 MODULAR EBS KNEE JOINT MODULAR EBS KNEE JOINT ISY OTTO BOCK HEALTHCARE GMBH 3R60

    Patients

    Seq Age Sex Outcome Treatment
    1