BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLUMBUS

    MDR report key: 18246978 · Received December 1, 2023

    Report

    Report Number
    9610612-2023-00251
    Event Type
    Injury
    Date Received
    December 1, 2023
    Report Date
    March 9, 2024
    Manufacturer
    AESCULAP AG
    Product Code
    OOG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H6 - CODES UPDATED INVESTIGATION RESULTS: THE COMPLAINED PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION. NEITHER AN ARTICLE NUMBER NOR LOT NUMBER COULD BE IDENTIFIED. THE TYPE OF COLUMBUS KNEE SYSTEM COULD ALSO NOT BE IDENTIFIED. THE PROVIDED PICTURES AND INFORMATION GIVE NO CLEAR HINTS REGARDING THE DEFINITIVE ROOT CAUSE FOR THE MENTIONED IMPLANT LOOSENING. BATCH HISTORY REVIEW: A REVIEW OF THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS IS NOT POSSIBLE SINCE THE LOT NUMBER IS UNKNOWN. ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3, THIS EVENT IS CONSIDERED REPORTABLE FOR THE FOLLOWING REASON - ADVERSE EVENT (NOT LATER THAN 30 DAYS). THE ASSESSMENT FOR THE REPORTABILITY OF THIS ADVERSE EVENT WAS BASED ON THE PATIENT HARM, REVISION. CONCLUSION AND MEASURES / PREVENTIVE MEASURES: BASED UPON THE INVESTIGATION RESULTS A CLEAR ROOT CAUSE CONCLUSION CANNOT BE DRAWN. IN THE EVENT THAT THE COMPLAINT PRODUCT WILL BE PROVIDED FOR INVESTIGATION IN THE FUTURE, AN UPDATE OF THIS REPORT WILL BE PROVIDED UNSOLICITED. BASED UPON THE INVESTIGATIONS RESULTS A CAPA IS NOT NECESSARY.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: THE COMPLAINED PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION. NEITHER AN ARTICLE NUMBER NOR LOT NUMBER COULD BE IDENTIFIED. THE TYPE OF COLUMBUS KNEE SYSTEM COULD ALSO NOT BE IDENTIFIED. THE PROVIDED PICTURES AND INFORMATION GIVE NO CLEAR HINTS REGARDING THE DEFINITIVE ROOT CAUSE FOR THE MENTIONED IMPLANT LOOSENING. BATCH HISTORY REVIEW: A REVIEW OF THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS IS NOT POSSIBLE SINCE THE LOT NUMBER IS UNKNOWN. ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3, THIS EVENT IS CONSIDERED REPORTABLE FOR THE FOLLOWING REASON - ADVERSE EVENT (NOT LATER THAN 30 DAYS). THE ASSESSMENT FOR THE REPORTABILITY OF THIS ADVERSE EVENT WAS BASED ON THE PATIENT HARM, REVISION. CONCLUSION AND MEASURES / PREVENTIVE MEASURES: BASED UPON THE INVESTIGATION RESULTS A CLEAR ROOT CAUSE CONCLUSION CANNOT BE DRAWN. IN THE EVENT THAT THE COMPLAINT PRODUCT WILL BE PROVIDED FOR INVESTIGATION IN THE FUTURE, AN UPDATE OF THIS REPORT WILL BE PROVIDED UNSOLICITED. BASED UPON THE INVESTIGATIONS RESULTS A CAPA IS NOT NECESSARY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE PRODUCT - UNKNOWN ITEM CODE OF COLUMBUS KNEE IMPLANT SYSTEM (AE-QAS-K521- 53). ACCORDING TO THE COMPLAINT DESCRIPTION, THE IMPLANT LOOSENED POSTOPERATIVELY AND THE PATIENT HAD SEVERAL REVISION SURGERIES. THE IMPLANTATION WITH VEGA SYSTEM WAS PERFORMED ON (B)(6) 2017 (RIGHT TOTAL KNEE REPLACEMENT). ON (B)(6) 2018, THE FIRST REVISION SURGERY WAS PERFORMED AS A RESULT OF ASEPTIC LOOSENING OF THE TIBIAL BASEPLATE. AFTERWARDS, IN (B)(6) 2019, A SECOND REVISION WAS PERFORMED DUE TO ASEPTIC LOOSENING OF THE FEMORAL COMPONENT. THE VEGA SYSTEM WAS REPLACED WITH COLUMBUS. A SCAR TISSUE ATTACHED TO THE KNEE CAP, "CLUNK LESION," WAS DISCOVERED IN (B)(6) 2021. THE PATIENT HAD TRAUMA FROM THE RIGHT KNEE REPLACEMENT THAT HAS CAUSED STENOSIS IN HER LUMBAR SPINE BILATERAL. PATIENT IS STILL HAVING CONSTANT PAIN IN THE RIGHT LEG, SWELLING, AND DIFFICULTY SLEEPING. ON (B)(6) 2022, A THIRD REVISION SURGERY WAS PERFORMED AND THE COLUMBUS SYSTEM WAS REPLACED WITH NON-AESCULAP PRODUCTS. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE 100034283 (400627519). ASSOCIATED MEDWATCH REPORTS: 400385689 (9610612-2018-00201) NX051Z. 400421112 (9610612-2019-00150) NX029Z.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1454137 COLUMBUS KNEE ENDOPROSTHETICS OOG AESCULAP AG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention