BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLUMBUS REV F TIBIA OFFSET CEMENTED T3+

    MDR report key: 12355678 · Received August 23, 2021

    Report

    Report Number
    9610612-2021-00489
    Event Type
    Injury
    Date Received
    August 23, 2021
    Date of Event
    July 20, 2016
    Report Date
    October 21, 2021
    Manufacturer
    AESCULAP AG
    Product Code
    JWH
    UDI-DI
    04046963338169
    PMA / PMN Number
    K083772
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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. 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. REVIEW OF THE COMPLAINT HISTORY REVEALED THAT NO SIMILAR COMPLAINTS HAVE BEEN FILED AGAINST PRODUCTS FROM THIS BATCH NUMBER. 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.

    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 NR076K - COLUMBUS REV F TIBIA OFFSET CEMENTED T3+. IT WAS REPORTED ON (B)(6) 2018, THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED LOOSENESS IN THE IMPLANT, PAIN AND DIFFICULTY WALKING, WHICH RESULTED IN A REVISION SURGERY. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2015, AND THE REVISION SURGERY OCCURRED ON (B)(6) 2016. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. CEMENT USED: BIOMET MV BONE CEMENT. A REVISION SURGERY WAS NECESSARY. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2020-00455 (400481542 + NR015K). INVOLVED COMPONENTS: NR015K - COLUMBUS REV F FEMUR CEMENTED F5R - 51869643. NR296K - FEMUR EXTENS.STEM 6¿ D18X157MM CEMENTED - 51622420. NR400K - NUT F/FEMUR EXTENS.STEM ALL SIZES NEUTR. - 52032922. NR196K - TIBIA OFFSET STEM D18X92MM CEMENTED - 51681838. NR133M - COLUMBUS REV F MC GLID.SURF.T3/3+ 16MM - 51885048.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1253404 COLUMBUS REV F TIBIA OFFSET CEMENTED T3+ KNEE ENDOPROSTHETICS JWH AESCULAP AG NR076K 51735538A 04046963338169

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NR015K - 51869643| NR133M - 51885048| NR196K - 51681838| NR296K - 51622420| NR400K - 52032922| NR015K - 51869643| NR133M - 51885048| NR196K - 51681838| NR296K - 51622420| NR400K - 52032922