BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VMP ENDURANCE 80G

    MDR report key: 21813341 · Received April 10, 2025

    Report

    Report Number
    1818910-2025-05454
    Event Type
    Malfunction
    Date Received
    April 10, 2025
    Date of Event
    March 18, 2025
    Manufacturer
    DEPUY IRELAND - 3015516266
    Product Code
    LOD
    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. ACCORDING TO THE INFORMATION RECEIVED, ¿IT WAS REPORTED THAT ON (B)(6) 2025 , THE PATIENT UNDERWENT AN UNKNOWN SURGERY. THE AMPOULE BOTTLE WAS FOUND TO BE BROKEN AT THE TIME OF OPENING THE PRODUCT. A SPARE PRODUCT WAS OPENED AND USED IN THE SURGERY." PRODUCT DESCRIPTION: VMP ENDURANCE 80G, PRODUCT CODE: 3172080, LOT NUMBER: 4221054, MANUFACTURING DATE: 23-JUN-2023, EXPIRY DATE: 31-MAY-2025, QUANTITY: (B)(4). THERE WERE ZERO NONCONFORMANCES ON THIS LOT. A REVIEW OF THE DHR HAS CONFIRMED THAT THERE WERE NO PROCESS ISSUES DOCUMENTED THAT COULD CONTRIBUTE TO THE EVENT DESCRIBED. 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 NUMBER: 4221054, MANUFACTURING DATE: 23-JUN-2023, EXPIRY DATE: 31-MAY-2025, QUANTITY: (B)(4). DEVICE HISTORY REVIEW : THERE WERE ZERO NONCONFORMANCES ON THIS LOT. A REVIEW OF THE DHR HAS CONFIRMED THAT THERE WERE NO PROCESS ISSUES DOCUMENTED THAT COULD CONTRIBUTE TO THE EVENT DESCRIBED.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. H11 ADDITIONAL NARRATIVE: D4/G4: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THEREFORE, (01)GTIN IS NOT AVAILABLE. 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

    IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN UNKNOWN SURGERY. THE AMPOULE BOTTLE WAS FOUND TO BE BROKEN AT THE TIME OF OPENING THE PRODUCT. A SPARE PRODUCT WAS OPENED AND USED IN THE SURGERY. THERE WAS NO IMPACT ON THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518518 VMP ENDURANCE 80G BONE CEMENT LOD DEPUY IRELAND - 3015516266 4221054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown