BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AS COLUMBUS REV F TIB.OFFSET CEMENT.T1+

    MDR report key: 11316852 · Received February 11, 2021

    Report

    Report Number
    9610612-2020-00688
    Event Type
    Injury
    Date Received
    February 11, 2021
    Report Date
    February 10, 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 · 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. THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS (DHR) WERE CHECKED FOR ALL AVAILABLE LOT NUMBERS AND WERE WITHIN SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. THERE ARE NO SIMILAR COMPLAINTS AGAINST THE SAME LOT NUMBER(S) WITH THIS ERROR PATTERN. 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 THAT THERE WAS AN ISSUE WITH NR072Z - AS COLUMBUS REV F TIB.OFFSET CEMENT.T1+. AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED KNEE PAIN, SWELLING, DIFFICULTY WALKING AND LOOSENING OF THE IMPLANT, WHICH RESULTED IN A REVISION SURGERY. THE PRIMARY SURGERY INVOLVING AN AESCULAP IMPLANT OCCURRED ON AN UNKNOWN DATE AND THE REVISION SURGERY OCCURRED ON (B)(6) 2017. 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). INVOLVED COMPONENTS: NR003Z (PS FEMUR CEMENTED F3L), NR400Z (FEMUR STEM NUT ALL SIZES NEUTRAL), NR291Z (FEMORAL STEM CEMENTED 6° NEUT D12X77MM), NR191Z (TIBIAL OFFSET STEM CEMENTED D12X52MM), NR614M (PS HC PE INSERT T1/T1+ 18MM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212730 AS COLUMBUS REV F TIB.OFFSET CEMENT.T1+ KNEE ENDOPROSTHETICS JWH AESCULAP AG NR072Z 52250077

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention