BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AE-QAS-K521-53

    MDR report key: 20975826 · Received December 19, 2024

    Report

    Report Number
    3005673311-2024-00001
    Event Type
    Injury
    Date Received
    December 19, 2024
    Report Date
    February 14, 2025
    Manufacturer
    AESCULAP AG
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION ON-GOING. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    UPDATE: A POLY SWAP HAD BEEN PLANNED BUT DID NOT OCCUR. HOWEVER, A REVISION TO A NON- AESCULAP IMPLANT SYSTEM WAS PROBABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A COMPONENT OF COLUMBUS KNEE IMPLANTS. ACCORDING TO THE COMPLAINT DESCRIPTION, A REVISION WAS PLANNED, AND THE TIBIAL POLYETHYLENE COMPONENT(S) ARE TO BE EXCHANGED. ADDITIONAL INFORMATION WAS NOT PROVIDED BUT HAS BEEN REQUESTED. THE ADVERSE EVENT IS FILED UNDER AESCULAP REFERENCE XC (B)(4) CC (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2023275 AE-QAS-K521-53 KNEE ENDOPROSTHETICS JWH AESCULAP AG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention