BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AS COLUMBUS REV FEM.SPACER DIST.F5 5MM

    MDR report key: 10495048 · Received September 4, 2020

    Report

    Report Number
    9610612-2020-00350
    Event Type
    Injury
    Date Received
    September 4, 2020
    Date of Event
    July 20, 2018
    Report Date
    February 23, 2021
    Manufacturer
    AESCULAP AG
    Product Code
    JWH
    PMA / PMN Number
    K083772
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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 NO LOT NUMBER WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE COMPLAINED DEVICE IS NOT POSSIBLE. 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 · 0

    THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH COLUMBUS REV FEM.SPACER. ACCORDING TO THE COMPLAINT DESCRIPTION THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED PAIN, DIFFICULTY WALKING, AND LOOSENING OF THE IMPLANT. PRIMARY SURGERY: (B)(6) 2014, REVISION SURGERY: (B)(6) 2017. CEMENT USED IS UNIDENTIFIED. A REVISION SURGERY WAS NECESSARY. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE REPORT WILL BE UPDATED ACCORDINGLY. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    959900 AS COLUMBUS REV FEM.SPACER DIST.F5 5MM KNEE ENDOPROSTHESES JWH AESCULAP AG NR465Z

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention