BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPUY CMW 2G 40G

    MDR report key: 18539705 · Received January 18, 2024

    Report

    Report Number
    1818910-2024-01342
    Event Type
    Malfunction
    Date Received
    January 18, 2024
    Date of Event
    January 1, 2023
    Report Date
    January 18, 2024
    Manufacturer
    DEPUY IRELAND - 3015516266
    Product Code
    LOD
    PMA / PMN Number
    K081163
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). THIS EVENT IS NOW BEING SUBMITTED UNDER THIS MRN NUMBER AND WILL NO LONGER BE SUBMITTED UNDER MRN 1818910-2024-00252. ANY FURTHER FOLLOW-UPS WILL CONTINUE TO BE SUBMITTED UNDER THIS CURRENT MRN. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, 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 REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # ==> (B)(4) INVESTIGATION SUMMARY ==> NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. LOT: 4200156 MANUFACTURING DATE: (B)(6) 2023 EXPIRY DATE: 31 MAY 26 QUANTITY: (B)(4) PRODUCT CHECKED: RETAINED SAMPLES. REQUIRED TESTING: TM-T150 CEMENT SETTING TIME THERE IS ONE NON-CONFORMANCE ASSOCIATED WITH THIS BATCH. THE NON-CONFORMANCE WOULD HAVE NO IMPACT TO THE CEMENT PERFORMANCE. THE SAMPLES RETURNED WERE TESTED IN A TEMPERATURE AND HUMIDITY-CONTROLLED LABORATORY. LOT: 4200156 DOUGH TIME: 59 S (SPEC: 1 MIN 30S) MIX CHARACTERISTICS: FIRM SETTING TIME: 5 MIN 25S (SPEC: 4 MIN 00S TO 6 MIN 00S) THE CEMENT MIXED AND BEHAVED AS EXPECTED FOR THE PRODUCT TYPE AND MET THE APPROPRIATE CONTROL 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: 3325040 AND LOT NUMBER: 4200156 HAS NO NON-CONFORMANCES/ MANUFACTURING IRREGULARITIES RELATED TO THE MALFUNCTION WERE IDENTIFIED. H10 ADDITIONAL NARRATIVE: ADDED: D4 (EXPIRATION DATE), D10 AND H4.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). G4: NO 510K AS DEVICE IS NOT MARKETED IN THE UNITED STATES UNDER THIS PRODUCT CODE, BUT THE SAME/SIMILAR PRODUCT IS MARKETED IN THE US UNDER A DIFFERENT PRODUCT CODE. D2B: PROCODE INADVERTENTLY SUBMITTED AS "MBB", THE CORRECT PROCODE SHOULD BE "LOD".

    Description of Event or Problem · 0

    THE SURGEON DESCRIBED THE BONE CEMENT TO BE VERY RUNNY IN CONSISTENCY OVER THE PAST FEW MONTHS, AS WELL AS THE CEMENT¿S SETTING TIME TO DIFFER FROM THE USUAL. THE EVENTS OCCURRED DURING SURGERY, AND DID NOT CAUSE ANY SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2477487 DEPUY CMW 2G 40G BONE CEMENT : BONE CEMENT LOD DEPUY IRELAND - 3015516266 4200156
    510791 DEPUY CMW 2G 40G BONE CEMENT : BONE CEMENT LOD DEPUY IRELAND - 3015516266 4200156

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown DEPUY CMW 2G 40G