BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSETGMV ENDURANCE GENT 40G

    MDR report key: 8155370 · Received December 12, 2018

    Report

    Report Number
    1818910-2018-77873
    Event Type
    Injury
    Date Received
    December 12, 2018
    Date of Event
    November 14, 2018
    Report Date
    November 14, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LOD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: THE COMPLAINT STATES: ¿DURING STEM CEMENTATION, THE GMV CEMENT STARTED TO BECOME HARDEN BY 7MINS AND COMPLETELY HARDEN IN THE PATIENT BODY BY 11MINS WHICH IS MUCH EARLIER THAN EXPECTED AS STATED IN THE MANUAL CAUSING INCOMPLETE STEM IMPLANTATION. THE TEMPERATURE IN THE OT WAS AT 19.7 DEGREE DURING THE CEMENTATION PERIOD. PATIENT CONSEQUENCE? :YES PATIENT CONSEQUENCE DESCRIPTION:THE STEM WAS NOT FULLY SEATED IN THE CANAL CAUSING LEG LENGTH DISCREPANCY IN PATIENT. ACTION TAKEN FOR PROCEDURE:SURGEON HAS TO RELEASE THE SOFT TISSUE AROUND THE HIP TO ACCOMMODATE FOR THE HIP TIGHTNESS DUE TO THE DISCREPANCY.¿ RETAINED POWDER AND LIQUID SAMPLES OF THE COMPLAINT BATCH IN QUESTION WERE OBTAINED, CONDITIONED TO 23°C, AND MIXED IN THE LABORATORY IN A BEAKER UNDER VENTILATED, TEMPERATURE AND HUMIDITY-CONTROLLED CONDITIONS. THE TESTED CEMENT: COMBINED AS EXPECTED; WITH. A MEAN DOUGH TIME OF 3 MINS 35 SECONDS. AN END OF WORKING TIME OF 8 MINS 30 SECONDS. A MEAN SETTING TIME OF 10 MINS 52 SECONDS. THE APPEARANCE AND HANDLING CHARACTERISTICS OF THE CEMENT WERE AS EXPECTED WITH ALL RESULTS OBTAINED BEING WITHIN SPECIFICATION CRITERIA. THE CEMENT MIX WAS THIN/ WET, AND HANDLING WAS SOFT WITH SLIGHT FLOW ONCE DOUGHED, WHICH ARE TYPICAL CHARACTERISTICS OF THIS CEMENT. ALL RESULTS ARE WITHIN THE SPECIFICATION LIMITS FOR THIS PRODUCT. THE REPORTED FAILURE WAS NOT REPEATED IN THE TESTING OF THE RETAINED SAMPLES OF THIS BATCH. ROOT CAUSE CANNOT BE DETERMINED FROM THE RESULTS OF THIS TESTING. DVA-107020-FDE REV 6 WAS REVIEWED, AND FAST SETTING CEMENT IS RECOGNISED ON LINES 72, 73, 74, 75 AND 175 (SEE ATTACHMENT (B)(4) EXTRACT FROM DVA-107020-FDE REV 6.PDF¿). THE DFMEA WAS ALSO REVIEWED FOR DISCREPANCIES BETWEEN THE IFU AND THE SURGICAL EXPERIENCE. LINES 147 AND 148 REFER TO THE ISSUE WHEN IN RELATION TO A LACK OF TRANSLATION AVAILABLE IN THE NATIVE TONGUE OF THE SURGEON. IN EACH CASE, THE RISK IS CONSIDERED ¿AS LOW AS POSSIBLE¿ AND CANNOT BE FURTHER MITIGATED. IFU0630004 REV B: DIRECTIONS FOR USE LISTS 5 WAYS IN WHICH THE CEMENT CAN BE AFFECTED BY CHANGES TO ENVIRONMENTAL CONDITIONS. THERE IS NO CHECKLIST FROM THE HOSPITAL ATTACHED TO THE PROVIDED COMPLAINT INFORMATION TO CHECK STORAGE OR CONDITIONING ENVIRONMENTS. THE MIXING AND USE OF BONE CEMENT CAN BE SIGNIFICANTLY AFFECTED BY EXPOSURE TO HIGH OR LOW TEMPERATURES UP TO 24 HOURS BEFORE USE. THIS CAN CAUSE WIDE FLUCTUATIONS IN WORKING AND SETTING TIME. THE OPTIMUM TEMPERATURE FOR BONE CEMENT IS 23 DEGREES CELSIUS AS PER THE IFU. CONCLUSION AND FURTHER ACTION: A ROOT CAUSE CANNOT BE DETERMINED AS THE COMPLAINT PROBLEM HAS NOT BEEN POSSIBLE TO REPLICATE WITH THE TESTING OF THE RETAINED SAMPLE. HOWEVER, THE CONDITIONING AND STORAGE OF THE PRODUCT, OR THE OPERATING THEATRE TEMPERATURE COULD HAVE POTENTIALLY AIDED THE UNUSUAL BEHAVIOUR MENTIONED. 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: DHR REVIEW COMPLETED ON 10 JAN 19. 1 UNRELATED NON-CONFORMANCE ON THIS LOT NUMBER. FINAL MICRO AND STERILITY TESTS PASSED.

    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. (B)(4).

    Description of Event or Problem · 1

    DURING STEM CEMENTATION, THE GMV CEMENT STARTED TO BECOME HARDEN BY 7 MINS AND COMPLETELY HARDEN IN THE PATIENT BODY BY 11 MINS WHICH IS MUCH EARLIER THAN EXPECTED AS STATED IN THE MANUAL CAUSING INCOMPLETE STEM IMPLANTATION. THE TEMPERATURE IN THE OT WAS AT 19.7 DEGREE DURING THE CEMENTATION PERIOD. PATIENT CONSEQUENCE DESCRIPTION:THE STEM WAS NOT FULLY SEATED IN THE CANAL CAUSING LEG LENGTH DISCREPANCY IN PATIENT. ACTION TAKEN FOR PROCEDURE:SURGEON HAS TO RELEASE THE SOFT TISSUE AROUND THE HIP TO ACCOMMODATE FOR THE HIP TIGHTNESS DUE TO THE DISCREPANCY. THIS ADDED ABOUT 45 MINUTES TO THE SURGICAL DURATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    995860 SMARTSETGMV ENDURANCE GENT 40G BONE CEMENT : BONE CEMENT LOD DEPUY ORTHOPAEDICS, INC. 1818910 8805743

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention