BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLECT.NO.QAS KNEE IMPLANTS VEGA

    MDR report key: 6141845 · Received December 2, 2016

    Report

    Report Number
    3005673311-2016-00207
    Event Type
    Malfunction
    Date Received
    December 2, 2016
    Date of Event
    September 15, 2016
    Report Date
    April 12, 2017
    Manufacturer
    AESCULAP IMPLANT SYSTEMS
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: BASED ON THE CURRENT AVAILABLE INFORMATION IT IS NOT POSSIBLE TO CARRY-OUT AN INVESTIGATION. CONCLUSION AND ROOT CAUSE: BASED ON THE AVAILABLE INFORMATION IT IS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE LOOSENING. THE MOST LIKELY ROOT CAUSE OF THE FAILURE IS USER ERROR. RATIONAL: WE ASSUME THAT THE SURGEON DID NOT USE THE CEMENT AS INTENDED. NO CAPA IS NECESSARY.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). IT HAS BEEN REPORTED THAT THE PATIENT HAD A TOTAL KNEE ARTHROPLASTY PROCEDURE IN (B)(6) 2014. TWO YEARS LATER THE FEMORAL LOOSENING OCCURRED, THERE IS NO DETAILED INFORMATION PROVIDED OF THE EXACT DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793386 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