BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLECT.NO.QAS KNEE IMPLANTS VEGA

    MDR report key: 11355220 · Received February 19, 2021

    Report

    Report Number
    9610612-2020-00746
    Event Type
    Injury
    Date Received
    February 19, 2021
    Report Date
    February 19, 2021
    Manufacturer
    AESCULAP AG
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: AS OF THE DATE OF THIS REPORT THE COMPLAINT PRODUCT WAS NOT PROVIDED FOR INVESTIGATION. THEREFORE, A THOROUGH INVESTIGATION IS NOT POSSIBLE. DUE TO THE FACT THAT NEITHER AN ARTICLE NUMBER NOR A LOT NUMBER WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS MUST REMAIN INCOMPLETE. A CLEAR ROOT CAUSE CONCLUSION CANNOT BE DRAWN DUE TO THE NON-AVAILABILITY OF IMPORTANT INFORMATION AND THE DEVICE ITSELF. 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 COLUMBUS KNEE IMPLANT SYSTEM WAS IMPLANTED DURING A PRIMARY SURGERY OF THE LEFT KNEE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, FOLLOWING THE PRIMARY SURGERY, THE PATIENT EXPERIENCED LEFT KNEE PAIN, AS WELL AS LOOSENING AND INSTABILITY OF THE IMPLANT. THERE WAS NO REPORTED REVISION SURGERY. THE COMPLAINT DEVICE WAS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245459 COLLECT.NO.QAS KNEE IMPLANTS VEGA KNEE ENDOPROSTHETICS JWH AESCULAP AG AE-QAS-K521-56

    Patients

    Seq Age Sex Outcome Treatment
    1 Other