BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VMP ENDURANCE 80G

    MDR report key: 9268960 · Received November 1, 2019

    Report

    Report Number
    1818910-2019-113762
    Event Type
    Malfunction
    Date Received
    November 1, 2019
    Date of Event
    October 7, 2019
    Report Date
    October 8, 2019
    Manufacturer
    DEPUY CMW - 9610921
    Product Code
    LOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISION OF 21 CFR, PART 803. THE REPORT MAY BE BASED ON THE 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. PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY = THE COMPLAINT STATES: ¿IT WAS REPORTED THAT THE CEMENT (P/N: 3172080) WAS LUMPED UP IMMEDIATELY WHEN IT WAS MIXED DURING THE BHP SURGERY ON (B)(6) 2019, SO IT WAS HALTED TO USE. THE SURGERY WAS COMPLETED WITHIN A 30 MINUTES SURGICAL DELAY BY USING ALTERNATIVE CEMENT. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.¿ DEVICE HISTORY LOT = DEVICE HISTORY REVIEWED 19 NOV 19 0 NON-CONFORMANCES ON THIS LOT NUMBER (9167580) FINAL MICRO AND STERILITY TESTS PASSED. (B)(4) UNITS RELEASED. LOT EXPIRY DATE: 30 APRIL 2021. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). 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 · 1

    IT WAS REPORTED THAT THE CEMENT (P/N: 3172080) WAS LUMPED UP IMMEDIATELY WHEN IT WAS MIXED DURING THE BHP SURGERY ON (B)(6) 2019, SO IT WAS HALTED TO USE. THE SURGERY WAS COMPLETED WITHIN A 30 MINUTES SURGICAL DELAY BY USING ALTERNATIVE CEMENT. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1059555 VMP ENDURANCE 80G BONE CEMENT : BONE CEMENT LOD DEPUY CMW - 9610921 9167580

    Patients

    Seq Age Sex Outcome Treatment
    1