BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLECT.NO.QAS KNEE IMPLANTS VEGA

    MDR report key: 6064405 · Received October 28, 2016

    Report

    Report Number
    3005673311-2016-00192
    Event Type
    Malfunction
    Date Received
    October 28, 2016
    Report Date
    June 29, 2017
    Manufacturer
    AESCULAP IMPLANT SYSTEMS
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Additional Manufacturer Narrative · 1

    THE IMPLANT COMPONENT WAS LOOSE AND NEED TO BE REMOVED AND REPLACED. IT IS NOT CLEAR WHICH INTERFACE HAD LOOSENED (IMPLANT/CEMENT OR CEMENT/BONE). BASED ON THE CURRENT AVAILABLE INFORMATION IT IS POSSIBLE TO CARRY-OUT AN INVESTIGATION. BASED ON THE AVAILABLE INFORMATION IT IS NOT COMPLETELY POSSIBLE TO DETERMINE THE CAUSE OF THE LOOSENING. THE MOST LIKELY ROOT CAUSE OF THE FAILURE IS USER ERROR. A CAPA IS NOT NECESSARY.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: USA. IT WAS REPORTED BY A SURGEON OF A LOOSE FEMORAL COMPONENT THAT IS SEVEN YEARS OLD. IT IS REPORTED THAT IT IS A CEMENTATION ISSUE. THE SURGEON ONLY HAVE FEMURS THAT WERE LOOSENED AND WENT FROM DOING HYBRID TOTAL KNEE ARTHROPLASTY PROCEDURES TO CEMENTING BOTH COMPONENTS. MULTIPLE INSTANCES REFERRED TO NO PATIENT SPECIFIC INFORMATION RECEIVED; ADDITIONAL INFORMATION REQUEST THIS REPORT WILL BE UPDATED IF INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716682 COLLECT.NO.QAS KNEE IMPLANTS VEGA KNEE ENDOPROSTHETICS JWH AESCULAP IMPLANT SYSTEMS AE-QAS-K521-56

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R