BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VMP ENDURANCE 50G

    MDR report key: 8484067 · Received April 4, 2019

    Report

    Report Number
    1818910-2019-89813
    Event Type
    Malfunction
    Date Received
    April 4, 2019
    Report Date
    March 18, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 DESCRIPTION CANNOT BE CONFIRMED AS THE BROKEN DEVICE WAS NOT RETURNED FOR INVESTIGATION, AND NO FURTHER EVIDENCE WAS SUPPLIED. DURING PRODUCTION, THE TIP OF THE AMPOULE IS REMOVED USING A FLAME, FILLED WITH MONOMER, AND THEN RESEALED WITH ANOTHER FLAME. THE AMPOULE CONDITION IS CHECKED AT SEVERAL POINTS THROUGHOUT THE MANUFACTURING PROCESS AND IF THE BREAK HAD BEEN APPARENT AT ANY POINT, THE AMPOULE WOULD BE REJECTED AND DISPOSED OF AS PER PROCEDURE. THE COMPLAINT DESCRIPTION COULD NOT IDENTIFY THE LOCATION OF THE AMPOULE BREAK. THE SET OF RETAINED SAMPLES FOR THIS BATCH WERE INSPECTED FOR SIGNS OF BROKEN AMPOULES, NONE WERE FOUND. DVA-107020-FDE REV 8 INCLUDES THIS FAILURE MODE ON LINES 115 AND 116. SEE ATTACHMENT ¿(B)(4) EXTRACT FROM DVA-107020-FDE REV 8.PDF¿. THE RISKS IDENTIFIED FOR THIS FAILURE ARE ¿AS LOW AS POSSIBLE¿ AND CANNOT BE FURTHER MITIGATED. THE MOST LIKELY ROOT CAUSE FOR CONFIRMED AMPOULE BREAKAGES RELATES TO TRANSIT DAMAGE. IN CONCLUSION, THIS IS A KNOWN FAILURE MODE AND THE CURRENT RATE OF COMPLAINTS FOR THIS ISSUE IS WITHIN THE EXPECTED OCCURRENCE RATE. NO INFORMATION RECEIVED WITH THIS INDIVIDUAL COMPLAINT INDICATED THAT A BROADER INVESTIGATION OR CORRECTIVE ACTION WAS NECESSARY THE NUMBER OF COMPLAINTS RECEIVED FOR THIS FAILURE MODE WILL CONTINUE TO BE MONITORED AND PRODUCT UPDATES/ RECOMMENDATIONS WILL BE IMPLEMENTED AT THE POST MARKET SURVEILLANCE REVIEW DEPENDENT UPON OCCURRENCE RATINGS. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS REQUIRED. DEVICE HISTORY LOT: DEVICE HISTORY REVIEWED: 0 NON-CONFORMANCES ON THIS LOT NUMBER. FINAL MICRO AND STERILITY TESTS PASSED. DEVICE HISTORY BATCH: NULL. DEVICE HISTORY REVIEW: NULL. 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

    (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

    TKA SURGERY WAS PERFORMED BY USING POLO IMPLANTS ON (B)(6) 2019. IT WAS REPORTED THAT THE AMPOULE OF THE CEMENT WAS ALREADY BROKEN WHEN IT WAS OPENED. THERE WERE NO DETAILS OF THE SURGERY HOWEVER IT WAS REPORTED THAT THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274834 VMP ENDURANCE 50G BONE CEMENT : BONE CEMENT LOD DEPUY ORTHOPAEDICS, INC. 1818910 8723769

    Patients

    Seq Age Sex Outcome Treatment
    1