BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPUY CMW 2G 40G

    MDR report key: 17801300 · Received September 22, 2023

    Report

    Report Number
    1818910-2023-19341
    Event Type
    Malfunction
    Date Received
    September 22, 2023
    Date of Event
    January 1, 2023
    Report Date
    September 22, 2023
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LOD
    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). INVESTIGATION SUMMARY: AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. 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. HOWEVER, IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE.

    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 : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. ACCORDING TO THE INFORMATION RECEIVED "THEY'VE SAID THAT IT APPEARS TO BE SETTING EXTREMELY SLOWLY, THEN ALL OF A SUDDEN IT WILL SET COMPLETELY." A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE:3325040, LOT - 4170440 AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED MANUFACTURING DATE: 04 MAY 23 EXPIRY DATE: 30 APR 2026. QUANTITY: (B)(4). DEVICE HISTORY REVIEWED: THERE WERE NO NON CONFORMANCES ASSOCIATED WITH THE BATCH. FINAL MICRO AND STERILITY TESTS PASSED. PRODUCT MET ALL QUALITY CONTROL ACCEPTANCE CRITERIA PRODUCT CHECKED: RETAINED SAMPLES. REQUIRED TESTING: TM-T150 CEMENT HANDLING THE RETAINED SAMPLES WERE TESTED IN A TEMPERATURE AND HUMIDITY-CONTROLLED LABORATORY DOUGH TIME: 46 SECS (SPEC: 1 MIN 30S MAX) MIX CHARACTERISTICS: FIRM SETTING TIME: 5 MIN 20 SECS (SPEC: 4 MIN TO 6 MIN). THE CEMENT MIXED AND BEHAVED AS EXPECTED FOR THE PRODUCT TYPE AND MET APPROPRIATE SPECIFICATIONS (MS-005, DEPUY CMW 2G GENTAMICIN BONE CEMENT). 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, LOT - 4170440 AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). D4: THE DEVICE CATALOG NUMBER IS UNKNOWN; THEREFORE, UDI IS UNAVAILABLE. B3: DATE OF EVENT IS AN UNKNOWN DATE IN 2023. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CEMENT APPEARS TO BE SETTING EXTREMELY SLOWLY, THEN ALL OF A SUDDEN IT WILL SET COMPLETELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1817949 DEPUY CMW 2G 40G BONE CEMENT LOD DEPUY ORTHOPAEDICS INC US 4170440

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown