BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEPUY CMW 3G GENTAMICIN 40G

    MDR report key: 21420457 · Received February 20, 2025

    Report

    Report Number
    1818910-2025-02811
    Event Type
    Death
    Date Received
    February 20, 2025
    Date of Event
    January 24, 2025
    Manufacturer
    DEPUY CMW - 9610921
    Product Code
    MBB
    UDI-DI
    10603295357391
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE: 3335040 LOT NUMBER: 4071992, AND NO NON-CONFORMANCES OR MANUFACTURING IRREGULARITIES WERE IDENTIFIED. ALL QC AND MICROBIOLOGY TESTING MET SPECIFICATION. THERE ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF BONE CEMENTS INCLUDING SERIOUS ADVERSE EVENTS CONCERNING POTENTIAL BLOOD PRESSURE AND CARDIOVASCULAR ISSUES THAT COULD RESULT IN FATAL OUTCOMES DURING THE CEMENTATION AND IMPLANTATION PROCESS. OUR INSTRUCTION FOR USE (IFU) PROVIDES AWARENESS OF THESE ADVERSE EVENTS AND COMPLICATIONS. A COMPLAINT SEARCH FOR GENTAMICIN BONE CEMENT WAS PERFORMED AND NO PREVIOUS COMPLAINTS WERE FOUND RELATED TO A FATAL OUTCOME. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS IS ALSO CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. BASED ON THE INVESTIGATION, NO CORRECTIVE AND/OR PREVENTIVE ACTIONS WERE IDENTIFIED. DEVICE HISTORY LOT: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE: 3335040 LOT NUMBER: 4071992, AND NO NON-CONFORMANCES OR MANUFACTURING IRREGULARITIES WERE IDENTIFIED. DEVICE HISTORY BATCH: NULL DEVICE HISTORY REVIEW: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE: 3335040 LOT NUMBER: 4071992, AND NO NON-CONFORMANCES OR MANUFACTURING IRREGULARITIES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE: 3335040, LOT NUMBER: 4071992, AND NO NON-CONFORMANCES OR MANUFACTURING IRREGULARITIES WERE IDENTIFIED. ALL QC AND MICROBIOLOGY TESTING MET SPECIFICATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE: 3335040 LOT NUMBER: 4071992, AND NO NON-CONFORMANCES OR MANUFACTURING IRREGULARITIES WERE IDENTIFIED. DEVICE HISTORY REVIEW: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE: 3335040 LOT NUMBER: 4071992, AND NO NON-CONFORMANCES OR MANUFACTURING IRREGULARITIES WERE IDENTIFIED. H11 ADDITIONAL NARRATIVE: CORRECTED: D3, G1 (MANUFACTURING SITE NAME).

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DEPUY ORTHOPAEDICS IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY ORTHOPAEDICS HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY ORTHOPAEDICS OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY ORTHOPAEDICS, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H11 ADDITIONAL NARRATIVE: D4/G4: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THEREFORE, (01)GTIN IS NOT AVAILABLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H11 ADDITIONAL NARRATIVE: CORRECTED: REMOVED PATIENT CODE: CARDIOVASCULAR INSUFFICIENCY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE FOR IMPLANTATION OF HIP ENDOPROSTHESIS UTILIZING BONE CEMENT, THE PATIENT SUDDENLY BEGAN EXPERIENCING SYMPTOMS OF CARDIAC DISTRESS, ARREST AND ASYSTOLE. THE CONDITION AT THE TIME OF NOTIFICATION OF AN ADVERSE REACTION WAS SEVERE, WITHOUT DYNAMICS, UNSTABLE. MECHANICAL VENTILATION WAS CARRIED OUT. THE SEVERITY WAS DUE TO CARDIOVASCULAR, CEREBRAL, RESPIRATORY FAILURE. THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394347 DEPUY CMW 3G GENTAMICIN 40G BONE CEMENT : BONE CEMENT MBB DEPUY CMW - 9610921 4071992 10603295357391

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death