BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AS COLUMBUS REV F TIB.OFFSET CEMENT.T3+

    MDR report key: 10309113 · Received July 22, 2020

    Report

    Report Number
    9610612-2020-00276
    Event Type
    Injury
    Date Received
    July 22, 2020
    Report Date
    October 2, 2020
    Manufacturer
    AESCULAP AG
    Product Code
    JWH
    PMA / PMN Number
    K083772
    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. DUE TO THE FACT THAT NO LOT NUMBER WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE COMPLAINED DEVICE IS NOT POSSIBLE. 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 PRODUCT AS COLUMBUS REV F TIB. OFFSET. PATIENT RECEIVED A NON-AESCULAP IMPLANT IN THE PRIMARY SURGERY. DUE TO IMPLANT FAILURE, PATIENT UNDERWENT A REVISION SURGERY AND RECEIVED AN AS COLUMBUS REVISION KNEE SYSTEM IMPLANT. AFTER THE REVISION SURGERY, PATIENT CONTINUED TO EXPERIENCE LEFT KNEE PAIN. PATIENT UNDERWENT AN UNSPECIFIED SUBSEQUENT SURGERY ON THE LEFT KNEE, WHICH RESULTED IN A REVISION SURGERY. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2014 FOR THE NON-AESCULAP SURGERY AND THE FIRST REVISION SURGERY OCCURRED ON (B)(6) 2014; AND THE FOLLOW UP REVISION SURGERY OCCURED (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: NR576Z (PS FEMORAL AUGMENT POSTERIOR F6 10MM), NR406Z (FEMORAL STEM CEMENTLESS 5° NEUT D16X117MM), NR076Z (PS TIBIA CEMENTED T3+), NR176Z (TIBIAL OFFSET STEM CEMENTLESS D16X92MM), NR006Z (PS FEMUR CEMENTED F6 L), NR400Z (FEMUR STEM NUT ALL SIZES NEUT), NR132M (PS MC PE INSERT T3/T3+ 14MM). THE CEMENT USED DURING THE FIRST REVISION SURGERY IS BIOMET COBALT HV BONE CEMENT (402283). THE FIRST REVISION SURGERY WAS TO REPLACE A COMPETITOR COMPONENT, THE SECOND REVISION WAS TO REPLACE AN AESCULAP COMPONENT. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772049 AS COLUMBUS REV F TIB.OFFSET CEMENT.T3+ KNEE ENDOPROSTHETICS JWH AESCULAP AG NR076Z 51949965

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NR176Z - 51888446| NR406Z - 51891612| NR576Z - 51939417