BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AS COLUMBUS CR/PS TIB.PLAT.CEMENTED T1+

    MDR report key: 10309133 · Received July 22, 2020

    Report

    Report Number
    9610612-2020-00231
    Event Type
    Injury
    Date Received
    July 22, 2020
    Date of Event
    May 31, 2016
    Report Date
    September 2, 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 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. 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 AS COLUMBUS. AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED, KNEE PAIN AND DIFFICULTY WALKING, WHICH RESULTED IN A REVISION SURGERY. DURING THE REVISION SURGERY THE PHYSICIAN REPLACED THE TIBIAL COMPONENT WITH ANOTHER AS COLUMBUS TIBIAL COMPONENT AND ADDED AN AS COLUMBUS EXTENSION STEM. 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. INVOLVED COMPONENTS: PRIMARY SURGERY: NN261Z (TIBIAL OBTURATOR D12MM, L7MM), NN013Z (AS COLUMBUS CR FEMUR CEMENTED F3 RT), NN072Z (AS COLUMBUS CR/PS TIBIA CEMENTED T1+), NN481 (COLUMBUS PRI/REV PE PATELLA 3-PEGS P1), NN410 (COLUMBUS CR UC PE INSERT T1/T1+ 10 MM). CEMENT USED DURING PRIMARY SURGERY: ZIMMER PALACOS R RADIOPAQUE BONE CEMENT (00-1112-140-01) REVISION SURGERY: NN410 (COLUMBUS CR UC PE INSERT T1/T1+ 10 MM), NN263Z (AS COLUMBUS TIBIAL STEM CEMENTED D12MM L92MM), NN071Z (AS COLUMBUS CR/PS TIBIA CEMENTED T1). CEMENT USED DURING THE REVISION SURGERY: ZIMMER PALACOS R RADIOPAQUE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772777 AS COLUMBUS CR/PS TIB.PLAT.CEMENTED T1+ KNEE ENDOPROSTHETICS JWH AESCULAP AG NN072Z

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention (B)(4).| (B)(4).| (B)(4).| NN410-52111762