BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSET GHV GENTAMICIN 40G

    MDR report key: 8416315 · Received March 13, 2019

    Report

    Report Number
    1818910-2019-87144
    Event Type
    Malfunction
    Date Received
    March 13, 2019
    Date of Event
    February 27, 2019
    Report Date
    February 26, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHYSICIAN

    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 STATES: ¿SMARTSET GHV GENTAMICIN BONE CEMENT WAS FOUND TO BE IN SOLID FORM INSTEAD OF POWDER FORM WHEN OPEN INTRAOPERATIVELY¿ THE PRODUCT WAS NOT RECEIVED FOR INVESTIGATION. TWO RETAINED SAMPLES FROM THIS BATCH HAVE BEEN REVIEWED AND THE POWDER APPEARS IN ITS USUAL SLIGHTLY OFF-WHITE, FREE FLOWING FORM. THE CEMENT POWDER CONTAINS GENTAMICIN WHICH MAKES THE PRODUCT SUSCEPTIBLE TO ABSORBING MOISTURE WHEN EXPOSED TO THE ATMOSPHERE. THERE IS NO CHECKLIST ATTACHED TO THE COMPLAINT TO DESCRIBE THE OPERATING THEATRE CONDITIONS, BUT IF THE PRODUCT HAS BEEN EXPOSED TO MOISTURE IN A HUMID ENVIRONMENT, THIS CAN RESULT IN THE POWDER PARTICLES ABSORBING MOISTURE FROM THE ATMOSPHERE, CLUMPING TOGETHER AND HARDENING TO FORM AGGLOMERATED POWDER. THE MAXIMUM STORAGE TEMPERATURE IS ALSO DETAILED ON THE PRODUCT LABELLING AND IN THE INSTRUCTIONS FOR USE. DVA-107020-FDE REV 8 RECOGNISES THIS FAILURE MODE ON LINES 110 AND 111 (SEE ATTACHMENT ¿PC-000401704 EXTRACT FROM DVA-107020-FDE.PDF¿). THE RISKS FOR THIS FAILURE ARE CONSIDERED ¿AS LOW AS POSSIBLE¿ AND CANNOT BE FURTHER MITIGATED. CAPA-003707 WAS EFFECTIVELY IMPLEMENTED FOR THE ¿CONTROL OF EXPOSURE TO MOISTURE FOR GHV AFTER POWDER FILLING AND PRIOR TO FINAL PACKING¿ IN OCTOBER 2016. CAPA-005588 WAS EFFECTIVELY IMPLEMENTED FOR ¿GHV SIEVE TEST SAMPLING¿ IN NOVEMBER 2016. CAPA-004191 WAS EFFECTIVELY IMPLEMENTED IN JANUARY 2016 FOR THE ¿COMPLAINT TREND FOR SMARTSET GHV PRODUCT CODE 545035500 BATCH NUMBER 7915797¿. THE MOST RECENT CAPA-006498 ¿POWDER COMPACTION DURING BLENDING OF SMARTSET GHV¿ WAS CLOSED AS EFFECTIVE ON 22 NOV 17. 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 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.(B)(4).

    Description of Event or Problem · 1

    SMARTSET GHV GENTAMICIN BONE CEMENT WAS FOUND TO BE IN SOLID FORM INSTEAD OF POWDER FORM WHEN OPEN INTRAOPERATIVELY. SURGICAL DELAY OF 1 MINUTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210065 SMARTSET GHV GENTAMICIN 40G BONE CEMENT : BONE CEMENT LOD DEPUY ORTHOPAEDICS INC US 8801953

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR