BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSET GHV GENTAMICIN 40G

    MDR report key: 8121525 · Received November 30, 2018

    Report

    Report Number
    1818910-2018-76805
    Event Type
    Malfunction
    Date Received
    November 30, 2018
    Date of Event
    September 6, 2018
    Report Date
    November 16, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 : DEVICE HISTORY REVIEWED: 2 UNRELATED NON-CONFORMANCES ON THIS BATCH. FINAL MICRO AND STERILITY TESTS PASSED. COMPLAINTS DATABASE SEARCHED: A COMPLAINT DATABASE SEARCH ON THE PROVIDED LOT NUMBER FOUND 2 ADDITIONAL REPORTS, 1 RELATED TO A BROKEN AMPOULE, AND 1 UNRELATED. TOTAL FOR LOT NUMBER: 2 (B)(4) COMPLAINTS RECEIVED BY CMW IN THE LAST 12 MONTHS FOR THIS ISSUE BY PRODUCT CODE: 0, BY PRODUCT FAMILY: 0. STORAGE CONDITIONS CHECKED: NOT ABLE TO CHECK STORAGE CONDITIONS ONCE PRODUCT HAS BEEN DISPATCHED FROM SITE AND THERE IS NO CHECKLIST FROM THE HOSPITAL ATTACHED TO THE PROVIDED COMPLAINT INFORMATION. PRODUCT CHECKED: NO. FMEA REVIEWED: DVA-107020-FDE REV 6. IFU / LABEL CHECKED: N/A. PHOTOGRAPHS ATTACHED: N/A. THE COMPLAINT STATES ¿THE CEMENT KIT WAS NOT COMPLETELY CLOSED.¿ A SECOND TRANSLATION OF THE ORIGINAL PORTUGUESE DESCRIPTION SAYS ¿THE PACKAGING OF THE LIQUID PART OF THE CEMENT WAS CORRUPTED¿ WHICH IMPLIES A BROKEN AMPOULE. AS THE PRODUCT SAMPLE WAS NOT RETURNED FOR ANALYSIS, THIS INVESTIGATION IS BASED ON THE INFORMATION CONTAINED IN THIS COMPLAINT REPORT AND IS LIMITED. WITHOUT A SAMPLE OR PHOTOGRAPHS, IT IS NOT POSSIBLE TO ESTABLISH FURTHER INFORMATION FOR THE INVESTIGATION. IT CAN BE INFERRED FROM THE COMPLAINT DESCRIPTION THAT THE AMPOULE CONTAINING LIQUID MONOMER HAS BROKEN. WITHOUT FURTHER INFORMATION, IT IS NOT POSSIBLE TO DETERMINE WHEN THIS DAMAGE ORIGINATED OR HOW SERIOUS THE DAMAGE IS. FMEA DVA-107020-FDE REV 6 LINES 115 AND 116 REFER TO THIS FAILURE MODE (¿(B)(4),EXTRACT FROM DVA-107020-FDE REV 6.PDF¿. 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. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. COMPLAINTS DATABASE SEARCHED: A COMPLAINT DATABASE SEARCH FINDS NO ADDITIONAL REPORTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION. BASED ON THE INABILITY TO FIND ANY OTHER RELATED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT CODE, IT IS REASONABLE TO CONCLUDE THAT THERE ARE NO ANOMALIES REGARDING MANUFACTURING OR INSPECTION CONTAINED IN THE DEVICE HISTORY RECORDS THAT WOULD CONTRIBUTE TO THE REPORTED EVENT. TOTAL FOR LOT NUMBER:0. COMPLAINTS RECEIVED BY CMW IN THE LAST 12 MONTHS FOR THIS ISSUE BY PRODUCT CODE: 2. BY PRODUCT FAMILY:4 (2X SMARTSET GHV, 2X SMARTSET GMV). 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 · 0

    PRODUCT COMPLAINT # (B)(4). 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. H10 ADDITIONAL NARRATIVE:   (DEVICE)

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: DEVICE HISTORY REVIEWED: 2 UNRELATED NON-CONFORMANCES ON THIS BATCH. FINAL MICRO AND STERILITY TESTS PASSED. COMPLAINTS DATABASE SEARCHED: A COMPLAINT DATABASE SEARCH ON THE PROVIDED LOT NUMBER FOUND 2 ADDITIONAL REPORTS, 1 RELATED TO A BROKEN AMPOULE, AND 1 UNRELATED. TOTAL FOR LOT NUMBER: 2 ((B)(4)). COMPLAINTS RECEIVED BY CMW IN THE LAST 12 MONTHS FOR THIS ISSUE ¿ BY PRODUCT CODE: 0. BY PRODUCT FAMILY: 0. STORAGE CONDITIONS CHECKED: NOT ABLE TO CHECK STORAGE CONDITIONS ONCE PRODUCT HAS BEEN DISPATCHED FROM SITE AND THERE IS NO CHECKLIST FROM THE HOSPITAL ATTACHED TO THE PROVIDED COMPLAINT INFORMATION. PRODUCT CHECKED: NO. FMEA REVIEWED: DVA-107020-FDE REV 6. THE COMPLAINT STATES ¿THE CEMENT KIT WAS NOT COMPLETELY CLOSED.¿ A SECOND TRANSLATION OF THE ORIGINAL PORTUGUESE DESCRIPTION SAYS ¿THE PACKAGING OF THE LIQUID PART OF THE CEMENT WAS CORRUPTED¿ WHICH IMPLIES A BROKEN AMPOULE. AS THE PRODUCT SAMPLE WAS NOT RETURNED FOR ANALYSIS, THIS INVESTIGATION IS BASED ON THE INFORMATION CONTAINED IN THIS COMPLAINT REPORT AND IS LIMITED. WITHOUT A SAMPLE OR PHOTOGRAPHS, IT IS NOT POSSIBLE TO ESTABLISH FURTHER INFORMATION FOR THE INVESTIGATION. IT CAN BE INFERRED FROM THE COMPLAINT DESCRIPTION THAT THE AMPOULE CONTAINING LIQUID MONOMER HAS BROKEN. WITHOUT FURTHER INFORMATION, IT IS NOT POSSIBLE TO DETERMINE WHEN THIS DAMAGE ORIGINATED OR HOW SERIOUS THE DAMAGE IS. FMEA DVA-107020-FDE REV 6 LINES 115 AND 116 REFER TO THIS FAILURE MODE (B)(4)¿. 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. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT : DEVICE HISTORY REVIEWED: NO NON-CONFORMANCES ON THIS BATCH. FINAL MICRO AND STERILITY TESTS PASSED. COMPLAINTS DATABASE SEARCHED: A COMPLAINT DATABASE SEARCH FINDS NO ADDITIONAL REPORTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION. BASED ON THE INABILITY TO FIND ANY OTHER RELATED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT CODE, IT IS REASONABLE TO CONCLUDE THAT THERE ARE NO ANOMALIES REGARDING MANUFACTURING OR INSPECTION CONTAINED IN THE DEVICE HISTORY RECORDS THAT WOULD CONTRIBUTE TO THE REPORTED EVENT. TOTAL FOR LOT NUMBER:0. COMPLAINTS RECEIVED BY CMW IN THE LAST 12 MONTHS FOR THIS ISSUE ¿ BY PRODUCT CODE: 2. BY PRODUCT FAMILY:4 (2X SMARTSET GHV, 2X SMARTSET GMV). 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). INVESTIGATION SUMMARY: DEVICE HISTORY REVIEWED: 2 UNRELATED NON-CONFORMANCE'S ON THIS BATCH. FINAL MICRO AND STERILITY TESTS PASSED. COMPLAINTS DATABASE SEARCHED: A COMPLAINT DATABASE SEARCH ON THE PROVIDED LOT NUMBER FOUND 2 ADDITIONAL REPORTS, 1 RELATED TO A BROKEN AMPOULE, AND 1 UNRELATED. TOTAL FOR LOT NUMBER: 2 (COM-(B)(4), COM-(B)(4)) COMPLAINTS RECEIVED BY CMW IN THE LAST 12 MONTHS FOR THIS ISSUE ¿ BY PRODUCT CODE: 0 BY PRODUCT FAMILY: 0. STORAGE CONDITIONS CHECKED: NOT ABLE TO CHECK STORAGE CONDITIONS ONCE PRODUCT HAS BEEN DISPATCHED FROM SITE AND THERE IS NO CHECKLIST FROM THE HOSPITAL ATTACHED TO THE PROVIDED COMPLAINT INFORMATION. PRODUCT CHECKED: NO FMEA REVIEWED: DVA-107020-FDE REV 6 IFU / LABEL CHECKED: N/A PHOTOGRAPHS ATTACHED: N/A. THE COMPLAINT STATES ¿THE CEMENT KIT WAS NOT COMPLETELY CLOSED.¿ A SECOND TRANSLATION OF THE ORIGINAL PORTUGUESE DESCRIPTION SAYS ¿THE PACKAGING OF THE LIQUID PART OF THE CEMENT WAS CORRUPTED¿ WHICH IMPLIES A BROKEN AMPOULE. AS THE PRODUCT SAMPLE WAS NOT RETURNED FOR ANALYSIS, THIS INVESTIGATION IS BASED ON THE INFORMATION CONTAINED IN THIS COMPLAINT REPORT AND IS LIMITED. WITHOUT A SAMPLE OR PHOTOGRAPHS, IT IS NOT POSSIBLE TO ESTABLISH FURTHER INFORMATION FOR THE INVESTIGATION. IT CAN BE INFERRED FROM THE COMPLAINT DESCRIPTION THAT THE AMPOULE CONTAINING LIQUID MONOMER HAS BROKEN. WITHOUT FURTHER INFORMATION, IT IS NOT POSSIBLE TO DETERMINE WHEN THIS DAMAGE ORIGINATED OR HOW SERIOUS THE DAMAGE IS. FMEA DVA-107020-FDE REV 6 LINES 115 AND 116 REFER TO THIS FAILURE MODE (SEE ATTACHMENT ¿PC(B)(4) EXTRACT FROM DVA-(B)(4)-FDE REV 6.PDF¿. 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. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: DEVICE HISTORY REVIEWED: NO NON-CONFORMANCES ON THIS BATCH. FINAL MICRO AND STERILITY TESTS PASSED. COMPLAINTS DATABASE SEARCHED: A COMPLAINT DATABASE SEARCH FINDS NO ADDITIONAL REPORTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION. BASED ON THE INABILITY TO FIND ANY OTHER RELATED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT CODE, IT IS REASONABLE TO CONCLUDE THAT THERE ARE NO ANOMALIES REGARDING MANUFACTURING OR INSPECTION CONTAINED IN THE DEVICE HISTORY RECORDS THAT WOULD CONTRIBUTE TO THE REPORTED EVENT. TOTAL FOR LOT NUMBER:0 COMPLAINTS RECEIVED BY CMW IN THE LAST 12 MONTHS FOR THIS ISSUE ¿ BY PRODUCT CODE: 2 BY PRODUCT FAMILY:4 (2X SMARTSET GHV, 2X SMARTSET GMV). 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 CEMENT KIT WAS NOT COMPLETELY CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    961131 SMARTSET GHV GENTAMICIN 40G BONE CEMENT : BONE CEMENT LOD DEPUY ORTHOPAEDICS, INC. 1818910 8712974

    Patients

    Seq Age Sex Outcome Treatment
    1