BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AS ENDURO FEMORAL COMPONENT CEMENTED F1R

    MDR report key: 12396161 · Received August 31, 2021

    Report

    Report Number
    2916714-2021-00174
    Event Type
    Injury
    Date Received
    August 31, 2021
    Report Date
    October 8, 2021
    Manufacturer
    AESCULAP AG
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE EVALUATION: ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT, IF AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE COMPONENTS USED WERE THE FOLLOWING: 4X CEMENT BONE FULL DOSE RADIOPAQUE SIMPLEX (STRYKER) NR400Z1 AS NUT F/FEMUR EXTENS.STEM ALL SZ.NEUTR(AESCULAP INC.); IMPLANT SITE: RIGHT KNEE LOT NUMBER: 52553246. NR440Z AS FEMUR EXTENS.STEM 5° D20X177 CEM.LESS (AESCULAP INC.); IMPLANT SITE: RIGHT KNEE LOT NUMBER: 52350154. NR873Z AS ENDURO MENISCAL COMPONENT F1 16MM (AESCULAP INC.); IMPLANT SITE: RIGHT KNEE. INVESTIGATION RESULTS: AS OF THE DATE OF THIS REPORT THE COMPLAINT PRODUCT WAS NOT PROVIDED FOR INVESTIGATION. THEREFORE, A THOROUGH INVESTIGATION IS NOT POSSIBLE. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR THE AVAILABLE LOT NUMBER AND WERE FOUND TO BE ACCORDING TO OUR SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. REVIEW OF THE COMPLAINT HISTORY REVEALED THAT NO SIMILAR COMPLAINTS HAVE BEEN FILED AGAINST PRODUCTS FROM THIS BATCH NUMBER. CONCLUSION AND MEASURES / PREVENTIVE MEASURES: BASED UPON THE INVESTIGATION RESULTS A CLEAR ROOT CAUSE CONCLUSION CANNOT BE DRAWN. THERE IS NO INDICATION FOR A MATERIAL-, MANUFACTURING- OR DESIGN-RELATED FAILURE. 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

    ADDITIONAL INFORMATION RECEIVED ON 03.SEP. 2021. MULTIPLE UNSPECIFIED KNEE SURGERIES WERE PERFORMED PRIOR TO THIS. INITIAL SURGERY DATE : (B)(6) 2020. INVOLVED COMPONENTS: THE COMPONENTS USED WERE THE FOLLOWING: 4X CEMENT BONE FULL DOSE RADIOPAQUE SIMPLEX (STRYKER). NR400Z1 AS NUT F/FEMUR EXTENS.STEM ALL SZ.NEUTR(AESCULAP INC.); IMPLANT SITE: RIGHT KNEE LOT NUMBER: 52553246. NR440Z AS FEMUR EXTENS.STEM 5° D20X177 CEM.LESS (AESCULAP INC.); IMPLANT SITE: RIGHT KNEE LOT NUMBER: 52350154. NR873Z AS ENDURO MENISCAL COMPONENT F1 16MM (AESCULAP INC.); IMPLANT SITE: RIGHT KNEE.

    Description of Event or Problem · 0

    NO UPDATES.

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT, IF AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH AE-QAS-K521-55 - COLLECT.NO.QAS KNEE IMPLANTS ROTATE HINGE. ACCORDING TO THE COMPLAINT DESCRIPTION, THE PATIENT NEEDS THEIR CURRENT AESCULAP ENDURO AS KNEE REVISION FEMORAL COMPONENT CONVERTED TO A CUSTOMIZED FEMORAL COMPONENT THAT CAN FIX INTO THE REMAINING HEALTHY BONE. A REVISION SURGERY WAS NECESSARY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED AS OF THIS REPORT. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1299997 AS ENDURO FEMORAL COMPONENT CEMENTED F1R KNEE ENDOPROSTHETICS JWH AESCULAP AG NB017Z 52537585

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention