BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AS COLUMBUS CR/PS TIB.PLAT.CEMENTED T4+

    MDR report key: 10495064 · Received September 4, 2020

    Report

    Report Number
    9610612-2020-00463
    Event Type
    Injury
    Date Received
    September 4, 2020
    Date of Event
    April 9, 2018
    Report Date
    October 16, 2020
    Manufacturer
    AESCULAP AG
    Product Code
    JWH
    PMA / PMN Number
    K071220
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: THE AFFECTED DEVICE WAS NOT AVAILABLE FOR INVESTIGATION. THEREFORE AN INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS (DHR) WERE CHECKED FOR THEL AVAILABLE LOT NUMBER 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. 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.

    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 A COLUMBUS TIBIA PLATEAU. ACCORDING TO THE COMPLAINT DESCRIPTION AS A RESULT OF HAVING THE PRODUCT IMPLANTED THE PATIENT EXPERIENCED KNEE PAIN, SWELLING, DIFFICULTY IN WALKING AND INSTABILITY OF THE IMPLANT. PRIMARY SURGERY: (B)(6) 2016. REVISION SURGERY: (B)(6) 2017. 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
    960238 AS COLUMBUS CR/PS TIB.PLAT.CEMENTED T4+ KNEE ENDOPROSTHESES JWH AESCULAP AG NN078Z 52188592

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention