BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLECT.NO.QAS KNEE IMPL.MISC./UNKNOWN

    MDR report key: 11352954 · Received February 19, 2021

    Report

    Report Number
    9610612-2020-00401
    Event Type
    Injury
    Date Received
    February 19, 2021
    Report Date
    January 25, 2021
    Manufacturer
    AESCULAP AG
    Product Code
    JWH
    PMA / PMN Number
    K101281
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE AFFECTED DEVICE WAS NOT AVAILABLE FOR INVESTIGATION. THEREFORE AN INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. THE QUALITY AND MANUFACTURING HISTORY RECORDS CAN NOT BE APPROVED WITHOUT ARTICLE AND LOT NUMBER. THE DETERMINATION OF A DEFINITE ROOT CAUSE IS DUE TO THE NON-AVAILABILITY OF IMPORTANT INFORMATION AND THE DEVICE ITSELF NOT POSSIBLE. THE CONCLUSION FROM THE ROOT CAUSE ANALYSIS IS THAT A SYSTEMATIC DEVICE DEVIATION IS UNLIKELY SINCE THE RECEIVED COMPLAINTS ARE LIMITED TO CERTAIN HEALTH CARE INSTITUTIONS AND THEIR APPLICANTS. THE PARTICIPATION OF THE APPLICANTS IN THIS DEVIATION SCENARIO CANNOT BE EXCLUDED BY TODAY. BASED ON THE ROOT CAUSE ANALYSIS RESULT NO CORRECTIVE ACTIONS HAVE BEEN CARRIED OUT. AS A PREVENTIVE ACTION WE WERE IN CONTACT WITH THE AFFECTED HEALTH CARE INSTITUTIONS AND APPLICANTS IN ORDER TO REDUCE THE PROBABILITY OF RECURRENCE. THE COMPLAINTS WERE SUBMITTED TO AESCULAP AG AS A SUMMARY REPORT. IN ORDER TO EXAMINE FURTHER ACTIONS, ALL CASES FROM THE SUMMARY REPORT ARE PROCESSED AS VIGILANCE SUSPICION CASES AND ARE CONTINUOUSLY MONITORED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO AESCULAP INC. THAT A VEGA KNEE IMPLANT SYSTEM WAS IMPLANTED DURING A REVISION SURGERY OF THE RIGHT KNEE PERFORMED IN (B)(6) 2015. ACCORDING TO THE COMPLAINANT, FOLLOWING THE REVISION SURGERY, THE PATIENT EXPERIENCED RIGHT KNEE PAIN, SWELLING, DIFFICULTY WALKING, AND LOOSENING OF THE IMPLANT. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2017 IN WHICH A NON-AESCULAP MANUFACTURED DEVICE WAS IMPLANTED. THE COMPLAINT DEVICE WAS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244304 COLLECT.NO.QAS KNEE IMPL.MISC./UNKNOWN KNEE ENDOPROSTHETICS JWH AESCULAP AG AE-QAS-K521-99

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention