BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR EBS KNEE JOINT

    MDR report key: 6095332 · Received November 11, 2016

    Report

    Report Number
    9616494-2016-00030
    Event Type
    Malfunction
    Date Received
    November 11, 2016
    Report Date
    October 6, 2016
    Manufacturer
    OTTO BOCK HEALTHCARE GMBH
    Product Code
    ISY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WE RECEIVED THE DEVICE NOVEMBER 4TH, 2016. THE EVALUATION WAS CARRIED OUT AT THE MANUFACTURER'S SERVICE CENTER ON NOVEMBER 5TH, 2016. SEVERAL BOLTS ARE USED TO FIX THE DIFFERENT PARTS OF THE KNEE JOINT WHEN IT IS MOUNTED. THE THREADS OF THE BOLTS ARE COVERED WITH AN TWO-COMPONENT-ADHESIVE, WHICH IS HARDENING ONCE THE BOLT IS TIGHTENED. THIS IS TO ASSURE THAT THE PARTS ARE FIXED PERMANENTLY. AFTER EVALUATION WE FOUND THAT ONE BOLT IN THE UPPER POSTERIOR PART OF THE KNEE JOINT DISENGAGED. BOTH HYDRAULICS ARE DEFECTIVE, THE FRAME IS DAMAGED AND BUSHINGS ARE WORN. 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 A BOLT CAME OUT OF THE FRAME. NO FALL OR SIGNIFICANT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747330 MODULAR EBS KNEE JOINT MODULAR EBS KNEE JOINT ISY OTTO BOCK HEALTHCARE GMBH 3R60

    Patients

    Seq Age Sex Outcome Treatment
    1