BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPUY CMW 2G 20G

    MDR report key: 15927318 · Received December 6, 2022

    Report

    Report Number
    1818910-2022-24504
    Event Type
    Malfunction
    Date Received
    December 6, 2022
    Date of Event
    November 21, 2022
    Report Date
    December 6, 2022
    Manufacturer
    DEPUY CMW - 9610921
    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). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 3325020 AND LOT 3861178, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES RELATED TO THE MALFUNCTION WERE IDENTIFIED. DEVICE HISTORY LOT : A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 3325020 AND LOT 3861178, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES RELATED TO THE MALFUNCTION WERE IDENTIFIED.

    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). 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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO CONSEQUENCE FOR THE PATIENT AND NO DELAY IN THE PROCEDURE. AFFECTED SIDE WAS RIGHT KNEE.

    Description of Event or Problem · 0

    FOR ONE PATIENT THE DEVICE WAS USED ON A THP ON (B)(6) 2022 AND THE CEMENT HARDENED TOO QUICKLY (LESS THAN 5MINS) AND THE CUP DID NOT HOLD AND THERE IS A THP REVISION ON (B)(6) 2022. FOR THE SECOND PATIENT, 3 CEMENTS WERE USED ON A PTG ON (B)(6) 2022 AND ONE OF THE CEMENTS HARDENED TOO QUICKLY SO ONE HAD TO BE REMADE. THE COMPLAINTS (B)(4) AND (B)(4) ARE LINKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1358806 DEPUY CMW 2G 20G BONE CEMENT : BONE CEMENT LOD DEPUY CMW - 9610921 3861178

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown DEPUY CMW 2G 20G| DEPUY CMW 2G 20G