BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURO

    MDR report key: 20685592 · Received November 14, 2024

    Report

    Report Number
    2916714-2024-00181
    Event Type
    Injury
    Date Received
    November 14, 2024
    Report Date
    January 15, 2025
    Manufacturer
    AESCULAP AG
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: 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 TO AESCULAP INC. THAT AN ENURO HINGE PART # UNKNOWN) WAS IMPLANTED ON AN UNSPECIFIED DATE. ACCORDING TO THE COMPLAINANT THE PATIENT WAS SCHEDULED TO HAVE A REVISION ON AN UNSPECIFIED DATE. REPORTEDLY THE PATIENT NEEDS A POLY SWAP. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THIS TIME. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4).

    Description of Event or Problem · 0

    UPDATE: ADDITIONAL INFORMATION WAS RECEIVED. THE POLY SWAP WAS NOT PERFORMED; HOWEVER, A REVISION TO A NON- AESCULAP IMPLANT SYSTEM WAS PROBABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2223579 ENDURO KNEE ENDOPROSTHETICS JWH AESCULAP AG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention