BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLUMBUS

    MDR report key: 18246980 · Received December 1, 2023

    Report

    Report Number
    2916714-2023-00120
    Event Type
    Injury
    Date Received
    December 1, 2023
    Report Date
    April 17, 2024
    Manufacturer
    AESCULAP AG
    Product Code
    OOG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor 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

    INVESTIGATION RESULTS: THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. ADDITIONALLY, NO ON-SITE EVALUATION OF THE UNIT WAS PERFORMED AND NO PARTS WERE RETURNED FOR FAILURE ANALYSIS. THEREFORE, THE INVESTIGATION WAS NOT ABLE TO CONFIRM A DEVICE ISSUE THAT COULD BE ASSOCIATED WITH THE REPORTED EVENT. BATCH HISTORY REVIEW: THE DEVICE HISTORY RECORDS (DHR) WERE NOT ABLE TO BE REVIEWED AS NO LOT NUMBER WAS MADE AVAILABLE. HOWEVER, ALL DEVICE HISTORY RECORDS (DHR) ARE REVIEWED AND RELEASED ACCORDING TO DOCUMENTED PROCEDURES AND A DEVICE IS NOT RELEASED IF IT DOES NOT MEET REQUIREMENTS OR IS NONCONFORMING. CONCLUSION AND MEASURES / PREVENTATIVE MEASURES: A DEFINITIVE CONCLUSION REGARDING THE COMPLAINT INCIDENT CANNOT BE REACHED WITHOUT A PHYSICAL EXAMINATION OF THE COMPLAINT DEVICE.

    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 PERFOMED AND THE COLUMBUS SYSTEM WAS REPLACED WITH NON-AESCULAP PRODUCTS. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH REPORTS: (B)(4) (9610612-2018-00201) NX051Z; (B)(4) (9610612-2019-00150) NX029Z.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1454139 COLUMBUS KNEE ENDOPROSTHETICS OOG AESCULAP AG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention