BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VMP ENDURANCE 80G

    MDR report key: 20493354 · Received October 21, 2024

    Report

    Report Number
    1818910-2024-21886
    Event Type
    Malfunction
    Date Received
    October 21, 2024
    Date of Event
    October 15, 2024
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    HTQ
    UDI-DI
    10603295357148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. PRODUCT DESCRIPTION: VMP ENDURANCE 80G. PRODUCT CODE: 3172080. LOT NO: 4147293. QUANTITY OF MANUFACTURED: (B)(4). DATE OF MANUFACTURING: 20-APR-2023. EXPIRY DATE: 31-MAR-2026. 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: PRODUCT DESCRIPTION: VMP ENDURANCE 80G. PRODUCT CODE: 3172080. LOT NO: 4147293. QUANTITY OF MANUFACTURED: (B)(4). DATE OF MANUFACTURING: 20-APR-2023. EXPIRY DATE: 31-MAR-2026. DEVICE HISTORY REVIEW: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [LOT: 4147293], 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 THAT 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 THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT IS OBTAINED, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    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. 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 WAS RECEIVED AND STATES THAT: A. CAN YOU PLEASE CONFIRM THE PRODUCT CODE AND LOT NO OF THE REPORTED CEMENT?: NO FURTHER INFORMATION IS AVAILABLE. B. WAS THE PACKAGING OF THE ITEM DAMAGED?: NO FURTHER INFORMATION IS AVAILABLE. C. IS THERE ANY PATIENT HARM?: NO. D. IS THERE ANY SURGICAL DELAY?: NO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT A SURGERY VIA TOTAL KNEE REPLACEMENT AND THE AMPOULE WAS BROKEN. THE BREAKAGE OF THE AMPOULE WAS FOUND BEFORE ITS PACKAGE WAS OPENED. ANOTHER PRODUCT WAS USED IN THE SURGERY BECAUSE LIQUID HAD LEAKED INSIDE THE PACKAGE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1206531 VMP ENDURANCE 80G BONE CEMENT : BONE CEMENT HTQ DEPUY IRELAND - 9616671 4147293 10603295357148

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown