BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VMP ENDURANCE 80G

    MDR report key: 11618967 · Received April 6, 2021

    Report

    Report Number
    1818910-2021-07117
    Event Type
    Malfunction
    Date Received
    April 6, 2021
    Date of Event
    March 16, 2021
    Report Date
    March 17, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HTQ
    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: ¿IT WAS REPORTED THAT ON (B)(6) 2021, THE SURGERY WAS PERFORMED. DURING THE SURGERY, WHEN THE SURGEON MIXED THE CEMENT IN QUESTION, BUT HE COULDN¿T MIX THE CEMENT WELL AND COULDN¿T USE IT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30MINUTES DELAY. THERE WAS NO PROBLEM WITH THE CEMENT STORAGE AND THE SURGEON¿S TECHNIQUE BECAUSE THE CEMENT WAS STORED IN THE REFRIGERATOR AND THE SURGEON HAD MANY EXPERIENCES IN USE. NO FURTHER INFORMATION IS AVAILABLE. NO DEVICE WAS RETURNED FOR EXAMINATION. THERE IS INSUFFICIENT EVIDENCE TO CONFIRM THE COMPLAINT DESCRIPTION. THE COMPLAINT DESCRIPTION INCLUDES THE INFORMATION ¿THE CEMENT WAS STORED IN THE REFRIGERATOR¿. IFU-0630035 WAS REVIEWED AND IT INCLUDES THE STATEMENT ¿CEMENT COMPONENTS AND MIXING EQUIPMENT SHOULD BE STORED AT THE INTENDED OPERATING ROOM TEMPERATURE (AROUND 23°C (73°F)) FOR A MINIMUM OF 24 HOURS BEFORE USE. DO NOT PRE-CHILL THE CEMENT¿. THIS INDICATES USER ERROR AS THE ROOT CAUSE. DVA-104409-FDE REV 10 AND DVA-107020-FDE REV 10 WERE REVIEWED AND BOTH INCLUDE THIS POSSIBLE ERROR IN USE. IN EACH CASE, THE RISK IS CONSIDERED AS LOW AS POSSIBLE AND CANNOT BE FURTHER MITIGATED. 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: NO LOT IDENTIFICATION DETAILS SUPPLIED TO ENABLE DHR REVIEW.

    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

    IT WAS REPORTED THAT ON (B)(6) 2021, THE SURGERY WAS PERFORMED. DURING THE SURGERY, WHEN THE SURGEON MIXED THE CEMENT IN QUESTION, BUT HE COULDN¿T MIX THE CEMENT WELL AND COULDN¿T USE IT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30MINUTES DELAY. THERE WAS NO PROBLEM WITH THE CEMENT STORAGE AND THE SURGEON¿S TECHNIQUE BECAUSE THE CEMENT WAS STORED IN THE REFRIGERATOR AND THE SURGEON HAD MANY EXPERIENCES IN USE. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519560 VMP ENDURANCE 80G BONE CEMENT : BONE CEMENT HTQ DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1