BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLECT.NO.QAS KNEE IMPLANTS COLUMBUS

    MDR report key: 7049283 · Received November 21, 2017

    Report

    Report Number
    9610612-2017-00578
    Event Type
    Malfunction
    Date Received
    November 21, 2017
    Date of Event
    December 6, 2010
    Report Date
    March 6, 2018
    Manufacturer
    AESCULAP IMPLANT SYSTEMS
    Product Code
    KRO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING. DEVICE NOT RETURN.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: USA. PATIENT #4: PATIENT HAD A SIZE 4 COLUMBUS FEMUR AND SIZE 2 COLUMBUS TIBIA WITH 14 MM POLY THAT HAS BEEN DISLOCATING. PATIENT NEEDED A CUSTOM POLY TO CORRECT DISLOCATING. COMPONENTS IN USE LISTED AS CONCOMITANT DEVICES ARE: AE-QAS-K521-53 / COLLECT.NO.QAS KNEE IMPLANTS COLUMBUS, AE-QAS-K521-53 / COLLECT.NO.QAS KNEE IMPLANTS COLUMBUS, AE-QAS-K521-53 / COLLECT.NO.QAS KNEE IMPLANTS COLUMBUS.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: NO PRODUCT IS AT HAND. CONCLUSION AND ROOT CAUSE: NO PRODUCT AVAILABLE AND THEREFORE AN ANALYSIS IS NOT POSSIBLE. NO CAPA IS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828194 COLLECT.NO.QAS KNEE IMPLANTS COLUMBUS KNEE ENDOPROSTHETICS KRO AESCULAP IMPLANT SYSTEMS AE-QAS-K521-53

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R AE-QAS-K521-53 / COLLECT.NO.QAS KNEE IMPLANTS COLU| AE-QAS-K521-53 / COLLECT.NO.QAS KNEE IMPLANTS COLU| AE-QAS-K521-53 / COLLECT.NO.QAS KNEE IMPLANTS COLU