BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR EBS KNEE JOINT

    MDR report key: 5999268 · Received October 5, 2016

    Report

    Report Number
    9616494-2016-00025
    Event Type
    Malfunction
    Date Received
    October 5, 2016
    Report Date
    September 21, 2016
    Manufacturer
    OTTO BOCK HEALTHCARE GMBH
    Product Code
    ISY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVALUATION WAS CARRIED OUT AT THE MANUFACTURER'S SERVICE CENTER ON SEPTEMBER 26, 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 THE HEXAGON SOCKETS OF THE BOLTS ARE DAMAGED. WE ASSUME THAT THE BOLTS WERE TIGHTENED OR LOOSENED WITH NOT SUFFICIENT TOOLS SO THAT THE DAMAGE COULD OCCUR. BOTH BOLTS IN THE UPPER POSTERIOR PART OF THE KNEE JOINT WERE LOOSE. DUE TO FURTHER USAGE OF THE KNEE JOINT WITH LOOSE BOLTS THE ANTERIOR FRAME WAS BENT. 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 JOINT IS NOT FUNCTIONING PROPERLY. NO FALL OR SIGNIFICANT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652358 MODULAR EBS KNEE JOINT MODULAR EBS KNEE JOINT ISY OTTO BOCK HEALTHCARE GMBH 3R60

    Patients

    Seq Age Sex Outcome Treatment
    1