BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR EBS KNEE JOINT

    MDR report key: 6253227 · Received January 16, 2017

    Report

    Report Number
    9616494-2017-00003
    Event Type
    Malfunction
    Date Received
    January 16, 2017
    Report Date
    October 5, 2016
    Manufacturer
    OTTO BOCK HEALTHCARE GMBH
    Product Code
    ISY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT NOTIFICATION ASSOCIATED WITH THIS DEVICE DESCRIBED THAT THE BUSHINGS ARE BROKEN CAUSING THE BOLTS TO BACK OUT. NO SERIOUS INJURIES WERE SUSTAINED AS A RESULT OF THE FAILURE AND NO MEDICAL TREATMENT WAS REQUIRED. THE EVALUATION OF THIS DEVICE WAS CONDUCTED AT THE MANUFACTURER'S SERVICE CENTER ON NOVEMBER 21ST, 2016. AFTER EVALUATION, WE CAN CONFIRM THAT ALL BOLTS HAD LOOSENED. WE CAN EXCLUDE A MANUFACTURING FAULT. FURTHER DATA REGARDING USAGE AND PATIENT WERE REQUESTED. AFTER TWO ATTEMPTS TO GET THESE DATA, THEY ARRIVED DECEMBER 19TH, 2016. THE FINAL EVALUATION WAS CONDUCTED ON JANUARY 6TH, 2017. AN EXACT REASON FOR THE LOOSE BOLTS COULD NOT BE DETERMINED. 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 THE BUSHINGS ARE BROKEN CAUSING THE BOLTS TO BACK OUT. NO FALL OR INJURY OCCURRED DUE TO THIS FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36235 MODULAR EBS KNEE JOINT MODULAR EBS KNEE JOINT ISY OTTO BOCK HEALTHCARE GMBH 3R60

    Patients

    Seq Age Sex Outcome Treatment
    1