BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPUY CMW 2G 20G

    MDR report key: 16151891 · Received January 12, 2023

    Report

    Report Number
    1818910-2023-01115
    Event Type
    Malfunction
    Date Received
    January 12, 2023
    Date of Event
    January 2, 2023
    Report Date
    January 12, 2023
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY = THE DEVICE ASSOCIATED WITH THIS REPORT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. VISUAL EXAMINATION OF THE DEVICE FOUND A SMALL SAMPLE OF HARDENED CEMENT INSIDE A PLASTIC CONTAINER. BASED ON THE RESULTS OF THE RETAIN SAMPLE TESTING, IT CAN BE CONCLUDED THAT THE REPORTED CEMENT SETTING TIME MET THE APPROPRIATE CONTROL SPECIFICATION, THEREFORE THE REPORTED ALLEGATION CANNOT BE CONFIRMED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT =MANUFACTURING DATE: 2022-07-01. EXPIRY DATE: 2025-06-30. QUANTITY: (B)(4). 2 NON-CONFORMANCE ON THIS LOT NUMBER; NO IMPACT ON CEMENT PERFORMANCE. FINAL MICRO AND STERILITY TESTS PASSED. PRODUCT MET ALL QUALITY CONTROL ACCEPTANCE CRITERIA. DEVICE HISTORY REVIEW = A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [3325020 / 3861178] NUMBER, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES RELATED TO THE MALFUNCTION WERE IDENTIFIED DURING MANUFACTURING. MANUFACTURING DATE: 2022-07-01, EXPIRY DATE: 2025-06-30, QUANTITY: (B)(4). 2 NON-CONFORMANCE ON THIS LOT NUMBER; NO IMPACT ON CEMENT PERFORMANCE. FINAL MICRO AND STERILITY TESTS PASSED. PRODUCT MET ALL QUALITY CONTROL ACCEPTANCE CRITERIA.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. 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. 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 DURING A RIGHT TKP, THE CEMENT HARDENED AFTER 5 MINUTES.IT WAS THE THIRD TIME THE ISSUE OCCURRED WITH THE CUSTOMER COMPLAINTS (B)(4).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED INDICATES THAT THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2018180 DEPUY CMW 2G 20G BONE CEMENT : BONE CEMENT LOD DEPUY ORTHOPAEDICS INC US 3861178

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown