BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSETGMV ENDURANCE GENT 40G

    MDR report key: 8400482 · Received March 7, 2019

    Report

    Report Number
    1818910-2019-86747
    Event Type
    Malfunction
    Date Received
    March 7, 2019
    Date of Event
    February 19, 2019
    Report Date
    February 21, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LOD
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON 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: ¿PACKING DAMAGED. IT WAS REPORTED THAT DURING THE SURGERY, NOTED THE PACKING DAMAGED AS THE PHOTO SHOWS. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.¿ AS THE PRODUCT SAMPLE WAS NOT RETURNED FOR ANALYSIS, THIS INVESTIGATION IS BASED ON THE PHOTOGRAPH SUPPLIED BY THE HOSPITAL TEAM. THE AMPOULE BLISTER PACK SHOWS DISCOLOURATION CONSISTENT WITH MONOMER CONTACT AND HAS CRACKED JUST BELOW THE NECK OF THE AMPOULE ALONG THE SHOULDER EDGE. A SHARD OF GLASS FROM THE AMPOULE CAN BE SEEN IN THE HCP¿S HAND, CONFIRMING THE AMPOULE HAS TAKEN DAMAGE AND CAUSED THE MONOMER TO LEAK INTO THE PACKAGING. 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 6 LINES 115 AND 116 REFER TO THIS FAILURE MODE (SEE ATTACHMENT ¿PC-000394473 EXTRACT FROM DVA-107020-FDE REV 8.PDF¿. 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. IN CONFIRMED REPORTS OF THIS ISSUE, THE MOST PROBABLE ROOT CAUSE CAN BE TRACED TO TRANSPORT OR STORAGE. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    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

    PACKING DAMAGED. IT WAS REPORTED THAT DURING THE SURGERY, NOTED THE PACKING DAMAGED AS THE PHOTO SHOWS. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195008 SMARTSETGMV ENDURANCE GENT 40G BONE CEMENT : BONE CEMENT LOD DEPUY ORTHOPAEDICS, INC. 1818910 8801959C

    Patients

    Seq Age Sex Outcome Treatment
    1