BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AS ENDURO FEMORAL COMPONENT CEMENTED F2R

    MDR report key: 20447083 · Received October 14, 2024

    Report

    Report Number
    2916714-2024-00151
    Event Type
    Injury
    Date Received
    October 14, 2024
    Report Date
    November 22, 2024
    Manufacturer
    AESCULAP AG
    Product Code
    KRO
    UDI-DI
    04046963177546
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    OK, 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

    MANUFACTURING SITE EVALUATION: 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. THE DEVICE HISTORY RECORDS (DHR) WERE REVIEWED FOR THE AVAILABLE LOT NUMBER; THE DEVICE WAS FOUND TO BE WITHIN SPECIFICATION AT THE TIME OF PRODUCTION. 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. 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 AS ENDURO FEMORAL COMPONENTS CEMENTED F2R (PART# NB018Z) WAS IMPLANTED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT THE IMPLANT WAS TOO TIGHT. REPORTEDLY THE PATIENT IS SCHEDULED FOR A REVISION SURGERY ON AN UNSPECIFIED DATE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET PROVIDED. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE XC (B)(4) (AIC REFERENCE NO. (B)(4) 2916714-2024-00152 (AIC REFERENCE NO. (B)(4) 2916714-2024-00153 (AIC REFERENCE NO. (B)(4) 2916714-2024-00154 (AIC REFERENCE NO. (B)(4) 2916714-2024-00155 (AIC REFERENCE NO. (B)(4) 2916714-2024-00156 (AIC REFERENCE NO. (B)(4) 2916714-2024-00157 (AIC REFERENCE NO. (B)(4) 2916714-2024-00158 (AIC REFERENCE NO. (B)(4)

    Description of Event or Problem · 0

    IT WAS REPORTED TO AESCULAP INC. THAT AN AS ENDURO FEMORAL COMPONENT CEMENTED F2R (PART# NB018Z) WAS IMPLANTED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT THE IMPLANT WAS TOO TIGHT. REPORTEDLY THE PATIENT IS SCHEDULED FOR A REVISION SURGERY ON AN UNSPECIFIED DATE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET PROVIDED. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4). 2916714-2024-00151 (AIC REFERENCE NO. (B)(4)). 2916714-2024-00152 (AIC REFERENCE NO. (B)(4)). 2916714-2024-00153 (AIC REFERENCE NO. (B)(4)). 2916714-2024-00154 (AIC REFERENCE NO. (B)(4)). 2916714-2024-00155 (AIC REFERENCE NO. (B)(4)). 2916714-2024-00156 (AIC REFERENCE NO. (B)(4)). 2916714-2024-00157 (AIC REFERENCE NO. (B)(4)). 2916714-2024-00158 (AIC REFERENCE NO. (B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294804 AS ENDURO FEMORAL COMPONENT CEMENTED F2R PROSTHESIS, KNEE KRO AESCULAP AG NB018Z 52683327 04046963177546

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention