BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AS ENDURO FEMORAL COMPONENT CEMENTED F2L

    MDR report key: 18576507 · Received January 24, 2024

    Report

    Report Number
    9610612-2023-00293
    Event Type
    Injury
    Date Received
    January 24, 2024
    Date of Event
    December 12, 2023
    Report Date
    January 27, 2025
    Manufacturer
    AESCULAP AG
    Product Code
    KRO
    PMA / PMN Number
    K101815
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: ALL PARTS FROM THE MENISCAL COMPONENT: ROTATION AXIS / INLAY / LOCKING RING / BEARING FOR ROTATION AXIS WERE RECEIVED. THE LOCKING NUT (PART OF THE FEMORAL COMPONENT) WAS ALSO PROVIDED FOR INVESTIGATION. THE PROVIDED DEVICES SHOW NO UNUSUAL MATERIAL ABRASION; NO UNUSUAL UNEXPECTED DEVIATION COULD BE DETERMINED. THERE ARE NO INDICATION OF A METALLOSIS BASED ON THE DEVICES PROVIDED. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR ALL LEADING DEVICE(S) LOT NUMBERS AND THE PRODUCTS FOUND TO BE ACCORDING TO OUR SPECIFICATION VALID AT THE TIME OF PRODUCTION. THERE ARE NO SIMILAR COMPLAINTS AGAINST THE SAME LOT NUMBER. ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3, THIS EVENT IS CONSIDERED REPORTABLE FOR THE FOLLOWING REASON - ADVERSE EVENT (NOT LATER THAN 30 DAYS). THE ASSESSMENT FOR THE REPORTABILITY OF THIS ADVERSE EVENT WAS BASED ON THE PATIENT HARM, REVISION SURGERY. CONCLUSION/PREVENTIVE MEASURES: BASED UPON THE INVESTIGATION RESULTS, A DEFINITE ROOT CAUSE CANNOT BE DETERMINED. THERE IS NO INDICATION FOR A MATERIAL, MANUFACTURING, OR DESIGN-RELATED FAILURE. THE MENTIONED METALLOSIS COULD NOT BE CONFIRMED BECAUSE THERE ARE NO MATERIAL /METAL ABRASION ON THE PROVIDED DEVICES. NO TISSUE SAMPLES WERE TAKEN DURING THE REVISION WITH REGARD TO METALLOSIS. ACCORDING TO THE SURGEON "THERE WAS NO VISIBLE ABRASION ON METAL COMPONENTS. THE METALLOSIS WAS CLEARLY RECOGNIZABLE BY A MACROSCOPICALLY BLACK-COLORED SYNOVIA OF MASSIVE EXPRESSION." BASED UPON THE INVESTIGATION RESULTS, A CAPA IS NOT REQUIRED.

    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

    ADDITIONAL INFORMATION: H6 - CODES UPDATED INVESTIGATION RESULTS: NO DEVICES/EXPLANTS NOR PICTURES WERE PROVIDED. THE INVESTIGATION RESULTS WERE BASED UPON DEVICE HISTORY RECORDS, HISTORICAL DATA ANALYSIS, AND PATIENT AND EVENT INFORMATION. DEVICE HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR ALL LEADING DEVICE(S) LOT NUMBERS AND THE PRODUCTS FOUND TO BE ACCORDING TO OUR SPECIFICATION VALID AT THE TIME OF PRODUCTION. THERE ARE NO SIMILAR COMPLAINTS AGAINST THE SAME LOT NUMBERS. ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR 803, THIS EVENT IS CONSIDERED REPORTABLE FOR THE FOLLOWING REASON: - SERIOUS INJURY (REPORT NOT LATER THAN 30 DAYS). THE ASSESSMENT FOR THE REPORTABILITY OF THIS ADVERSE EVENT WAS BASED ON PATIENT HARM, REVISION SURGERY. CONCLUSION/PREVENTIVE MEASURES: ON THE BASIS OF THE CURRENT INFORMATION AND WITHOUT THE PRODUCT FOR INVESTIGATION, A CLEAR CONCLUSION REGARDING THE ROOT CAUSE FOR THE REVISION CANNOT BE DRAWN. THERE IS NO INDICATION FOR A MATERIAL DEFECT OR MANUFACTURING FAILURE ON THE BASIS OF REVIEW OF THE DEVICE HISTORY RECORDS. THE MENTIONED METALLOSIS CANNOT BE PROVEN AT THIS POINT. NO TISSUE SAMPLES WERE TAKEN DURING THE REVISION WITH REGARD TO METALLOSIS. ACCORDING TO THE SURGEON: "THERE WAS NO VISIBLE ABRASION ON METAL COMPONENTS. THE METALLOSIS WAS CLEARLY RECOGNIZABLE BY A MACROSCOPICALLY BLACK-COLORED SYNOVIA OF MASSIVE EXPRESSION." 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 INVESTIGATION RESULTS, A CAPA IS NOT NECESSARY.

    Description of Event or Problem · 0

    UPDATE: ASSOCIATED MEDWATCH REPORTS: 9610612-2023-00293 (AESCULAP AG REFERENCE NO. (B)(4) - NB015Z). 9610612-2024-00026 (AESCULAP AG REFERENCE NO.(B)(4) - NB011Z). 9610612-2024-00027 (AESCULAP AG REFERENCE NO. (B)(4) -NB025Z ). 9610612-2024-00028 (AESCULAP AG REFERENCE NO. (B)(4) - NR191Z). 9610612-2024-00029 (AESCULAP AG REFERENCE NO.(B)(4) - NB035Z). 9610612-2024-00030 (AESCULAP AG REFERENCE NO.(B)(4) - NR880Z). 9610612-2024-00031 (AESCULAP AG REFERENCE NO.(B)(4) - NR591Z). 9610612-2024-00032 (AESCULAP AG REFERENCE NO.(B)(4) - NR866Z). 9610612-2024-00033 (AESCULAP AG REFERENCE NO.(B)(4) - NR294Z).

    Description of Event or Problem · 0

    UPDATE: THE REVISION WAS PERFORMED ON (B)(6)2024. ASSOCIATED MEDWATCH REPORTS: 9610612-2023-00293 (AESCULAP AG REFERENCE NO. (B)(4) - NB015Z). 9610612-2024-00026 (AESCULAP AG REFERENCE NO. (B)(4) - NB011Z). 9610612-2024-00027 (AESCULAP AG REFERENCE NO. (B)(4) -NB025Z). 9610612-2024-00028 (AESCULAP AG REFERENCE NO. (B)(4) - NR191Z). 9610612-2024-00029 (AESCULAP AG REFERENCE NO. (B)(4) - NB035Z). 9610612-2024-00030 (AESCULAP AG REFERENCE NO. (B)(4) - NR880Z). 9610612-2024-00031 (AESCULAP AG REFERENCE NO. (B)(4) - NR591Z). 9610612-2024-00032 (AESCULAP AG REFERENCE NO. (B)(4) - NR866Z). 9610612-2024-00033 (AESCULAP AG REFERENCE NO. (B)(4) - NR294Z).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE PRODUCT NB015Z - AS ENDURO FEMORAL COMPONENT CEMENTED F2L. ACCORDING TO THE COMPLAINT DESCRIPTION, THE PATIENT EXPERIENCED PAIN AND SWELLING POSTOPERATIVELY. THE LAST IMPLANTATION HAD BEEN PERFORMED FIVE (5) MONTHS AGO, ON (B)(6)2023. A REVISION SURGERY WAS REQUIRED. METALLOSIS WAS AGAIN FOUND INTRAOPERATIVELY ON (B)(6)2023. ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR 803, SECTION 803.3, THIS EVENT IS CONSIDERED REPORTABLE FOR THE FOLLOWING REASON: - SERIOUS INJURY (REPORT NOT LATER THAN 30 DAYS). THE ASSESSMENT FOR THE REPORTABILITY OF THIS ADVERSE EVENT WAS BASED ON PATIENT HARM, REVISION SURGERY. FURTHER DETAILS WERE NOT PROVIDED. THE ADVERSE EVENT IS FILED UNDER AESCULAP AG REFERENCE NO. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1140812 AS ENDURO FEMORAL COMPONENT CEMENTED F2L KNEE ENDOPROSTHESES KRO AESCULAP AG NB015Z 52830432

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention