BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VMP ENDURANCE 80G

    MDR report key: 10246060 · Received July 8, 2020

    Report

    Report Number
    1818910-2020-15265
    Event Type
    Malfunction
    Date Received
    July 8, 2020
    Date of Event
    June 23, 2020
    Report Date
    June 22, 2020
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LOD
    PMA / PMN Number
    K033563
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : THE COMPLAINT STATES "THE SURGERY WAS PERFORMED ON (B)(6)2020. DURING THE SURGERY, WHEN THE SURGEON OPENED THE CEMENT (P/N: 3172080), HE FOUND THAT THE BOTTLE OF THE CEMENT HAD BROKEN, AND LIQUID HAD LEAKED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH ANOTHER PRODUCT. IT WAS UNKNOWN WHETHER THERE WAS ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE." AS THE PRODUCT SAMPLE WAS NOT RETURNED FOR ANALYSIS, THIS INVESTIGATION IS BASED ON THE INFORMATION CONTAINED IN THIS COMPLAINT REPORT AND IS LIMITED. THE COMPLAINT INFORMATION DESCRIBES A BROKEN AMPOULE. WITHOUT A SAMPLE OR PHOTOGRAPHS, IT IS NOT POSSIBLE TO ESTABLISH FURTHER INFORMATION FOR THE INVESTIGATION, SUCH AS WHEN THIS DAMAGE ORIGINATED OR HOW SERIOUS THE DAMAGE IS. IT IS NOT POSSIBLE TO CONFIRM THE COMPLAINT DESCRIPTION. RETAINED SAMPLES FROM THIS LOT NUMBER WERE CHECKED FOR SIGNS OF THIS FAILURE MODE, BUT NO FURTHER BROKEN AMPOULES WERE DISCOVERED. FMEA DVA-107020-FDE REV 9 LINES 115, 116, 144 AND 145 REFER TO THIS FAILURE MODE (SEE ATTACHMENT ¿PC-000719486 EXTRACT FROM DVA-107020-FDE.PDF¿. IN EACH CASE THE RISK IS CONSIDERED ¿AS LOW AS POSSIBLE¿ AND CANNOT BE FURTHER MITIGATED. 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 20 JULY 2020. 2 UNRELATED NON-CONFORMANCES ON THIS LOT NUMBER. FINAL MICRO AND STERILITY TESTS PASSED. 678 UNITS RELEASED. LOT EXPIRY DATE: 31-OCT-21.

    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

    THE SURGERY WAS PERFORMED ON (B)(6) 2020. DURING THE SURGERY, WHEN THE SURGEON OPENED THE CEMENT (P/N: 3172080), HE FOUND THAT THE BOTTLE OF THE CEMENT HAD BROKEN, AND LIQUID HAD LEAKED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH ANOTHER PRODUCT. IT WAS UNKNOWN WHETHER THERE WAS ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710994 VMP ENDURANCE 80G BONE CEMENT : BONE CEMENT LOD DEPUY ORTHOPAEDICS INC US 9353889

    Patients

    Seq Age Sex Outcome Treatment
    1