BEUDAMED
    FDA Adverse Event Death Summary report: N

    AS COLUMBUS CR FEMORAL COMP.CEMENTED F4R

    MDR report key: 15545831 · Received October 5, 2022

    Report

    Report Number
    9610612-2022-00289
    Event Type
    Death
    Date Received
    October 5, 2022
    Date of Event
    August 17, 2022
    Report Date
    November 16, 2022
    Manufacturer
    AESCULAP AG
    Product Code
    JWH
    PMA / PMN Number
    K071220
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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

    INVESTIGATION RESULTS: AS OF THE DATE OF THIS REPORT THE COMPLAINT PRODUCT WAS NOT PROVIDED FOR INVESTIGATION. THEREFORE, A THOROUGH INVESTIGATION IS NOT POSSIBLE. THIS CASE WAS AGAIN ADDITIONALLY PRESENTED TO THE SAFETY OFFICER. THERE ARE NO HINTS REGARDING A RELATION WITH THE PATIENT HARM AND THE IMPLANTED AESCULAP DEVICES. 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. PATTERN. THERE ARE NO SIMILAR COMPLAINTS AGAINST THE SAME LOT NUMBER(S) WITH THIS ERROR PATTERN. 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 ON THE INVESTIGATION RESULTS, A CAPA IS NOT NECESSARY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH NN014Z - AS COLUMBUS CR FEMORAL COMP.CEMENTED F4R. ACCORDING TO THE COMPLAINT DESCRIPTION, THE PATIENT HAD A POSTOPERATIVE CARDIAC ARREST AFTER 2 DAYS AND WAS FOUND IN THE HOSPITAL ROOM DECEASED. SHE HAD UNDERGONE A TOTAL KNEE REPLACEMENT (TKR) USING THE ORTHOPILOT ELITE NAVIGATION SYSTEM AND IQ COLUMBUS KNEE SYSTEM. THE SURGEON NOTED THAT THE OPERATION WENT SMOOTHLY. . THE AUTOPSY RESULTS CONFIRMED THE CAUSE OF DEATH. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). INVOLVED COMPONENTS: 400570775 GE331SU SAW BLADE STRYKER SYSTEM 6 90/19/1.27MM/LOT 52753234. 400570776 NN412 COLUMBUS UC GLIDING SURFACE T1/1+ 14MM/LOT 52618073. 400570777 NN261Z AS TIBIAL OBTURATOR D12MM/LOT 52741981. 400570778 NN072Z AS COLUMBUS CR/PS TIB.PLAT.CEMENTED T1+/LOT 52582230. 400570779 T860010 NANOGEL 1ML/LOT8621391. 400570780 T860010 NANOGEL 1ML/LOT 8622061. 400570782 FS618SU ORTHOPILOT CAP SINGLE-USE MARKERS.

    Description of Event or Problem · 0

    INVOLVED COMPONENTS: (B)(6) GE331SU SAW BLADE STRYKER SYSTEM 6 90/19/1.27MM/LOT 52753234. (B)(6) NN412 COLUMBUS UC GLIDING SURFACE T1/1+ 14MM/LOT 52618073. (B)(6) NN261Z AS TIBIAL OBTURATOR D12MM/LOT 52741981. (B)(6) NN072Z AS COLUMBUS CR/PS TIB.PLAT.CEMENTED T1+/LOT 52582230. (B)(6) T860010 NANOGEL 1ML/LOT8621391. (B)(6) T860010 NANOGEL 1ML/LOT 8622061. (B)(6) FS618SU ORTHOPILOT CAP SINGLE-USE MARKERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2504907 AS COLUMBUS CR FEMORAL COMP.CEMENTED F4R KNEE ENDOPROSTHESES JWH AESCULAP AG NN014Z 52705384

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Female Death FS618SU ORTHOPILOT CAP SINGLE-USE MARKERS| GE331SU SAW BLADE STRYKER SYSTEM 6 90/19/1.27MM/L| NN072Z AS COLUMBUS CR/PS TIB.PLAT.CEMENTED T1+/LO| NN261Z AS TIBIAL OBTURATOR D12MM/LOT 52741981| NN412 COLUMBUS UC GLIDING SURFACE T1/1+ 14MM/LOT| T860010 NANOGEL 1ML/LOT 8622061| T860010 NANOGEL 1ML/LOT8621391