BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPUY CMW 3G GENTAMICIN 40G

    MDR report key: 8864720 · Received August 6, 2019

    Report

    Report Number
    1818910-2019-100166
    Event Type
    Malfunction
    Date Received
    August 6, 2019
    Date of Event
    July 17, 2019
    Report Date
    July 17, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    MBB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. H10 ADDITIONAL NARRATIVE: PRODUCT COMPLAINT # :(B)(4). INVESTIGATION SUMMARY ==> THE COMPLAINT STATES: ¿HI TOM THANKYOU FOR DISCUSSING THE INCIDENT WE HAD AT LGH WITH CEMENT SETTING TOO FAST (7MINS). FOLLOWING UP THE NUMBERS ARE REF 3335-040 LOT 9039324 EXP 2021-12-31 REF 3335-040 LOT 8914464 EXP 2021-08-31 WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? --> NO.¿ THE SPECIFICATION FOR SETTING TIME FOR DEPUY CMW 3 IS RANGED BETWEEN 8½ AND 9½ MINUTES WHEN USED AT THE RECOMMENDED 23°C. THE RETAINED SAMPLES WERE TESTED IN A TEMPERATURE AND HUMIDITY CONTROLLED LABORATORY (SEE ATTACHMENT ¿(B)(4) RETEST RESULTS.PDF¿). 9039324 MEAN DOUGH TIME: MEAN SETTING TIME: END OF WORKING TIME: HANDLING CHARACTERISTICS: 8914464 MEAN DOUGH TIME: 2MIN 24SEC MEAN SETTING TIME: 8MIN 12SEC END OF WORKING TIME: 6MIN 50SEC HANDLING CHARACTERISTICS: FIRM. THE REPORTED FAILURE WAS NOT REPEATED IN THE TESTING OF THE RETAINED SAMPLES OF THIS BATCH. THE COMPLAINT DESCRIPTION CANNOT BE CONFIRMED FROM THE RESULTS OF THIS TESTING. ROOT CAUSE CANNOT BE DETERMINED FROM THE RESULTS OF THIS TESTING. DVA-107020-FDE REV 8 WAS REVIEWED, AND FAST SETTING CEMENT IS RECOGNISED ON LINES 72, 73, 74, 75 AND 175 (SEE ATTACHMENT ¿PC-000506753 EXTRACT FROM DVA-107020-FDE.PDF¿). IN EACH CASE, THE RISK IS CONSIDERED ¿AS LOW AS POSSIBLE¿ AND CANNOT BE FURTHER MITIGATED. 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. VACUUM MIXING OF CEMENT CAN NOTICEABLY ACCELERATE THE SETTING TIME OF MIXED CEMENT. 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 ==> DEVICE HISTORY REVIEWED: 9039324 1 UNRELATED NON-CONFORMANCE ON THIS LOT NUMBER. FINAL MICRO AND STERILITY TESTS PASSED. 2740 UNITS RELEASED. LOT EXPIRY DATE: 31 DECEMBER 2021. 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

    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. ADDED: (FUNCTIONAL : CEMENT SETTING TIME). PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : THE COMPLAINT STATES: ¿HI (B)(4) THANK YOU FOR DISCUSSING THE INCIDENT WE HAD AT (B)(6) WITH CEMENT SETTING TOO FAST (7MINS). FOLLOWING UP THE NUMBERS ARE REF 3335-040 LOT 9039324 EXP 2021-12-31 REF 3335-040 LOT 8914464 EXP 2021-08-31 WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO.¿ THE SPECIFICATION FOR SETTING TIME FOR DEPUY CMW 3 IS RANGED BETWEEN 8½ AND 9½ MINUTES WHEN USED AT THE RECOMMENDED 23°C. THE RETAINED SAMPLES WERE TESTED IN A TEMPERATURE AND HUMIDITY CONTROLLED LABORATORY. 9039324: MEAN DOUGH TIME: . MEAN SETTING TIME: . END OF WORKING TIME: . HANDLING CHARACTERISTICS: . 8914464: MEAN DOUGH TIME: 2MIN 24SEC. MEAN SETTING TIME: 8MIN 12SEC. END OF WORKING TIME: 6MIN 50SEC. HANDLING CHARACTERISTICS: FIRM. THE REPORTED FAILURE WAS NOT REPEATED IN THE TESTING OF THE RETAINED SAMPLES OF THIS BATCH. THE COMPLAINT DESCRIPTION CANNOT BE CONFIRMED FROM THE RESULTS OF THIS TESTING. ROOT CAUSE CANNOT BE DETERMINED FROM THE RESULTS OF THIS TESTING. (B)(4) WAS REVIEWED, AND FAST SETTING CEMENT IS RECOGNISED ON LINES 72, 73, 74, 75 AND 175. IN EACH CASE, THE RISK IS CONSIDERED ¿AS LOW AS POSSIBLE¿ AND CANNOT BE FURTHER MITIGATED. 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. VACUUM MIXING OF CEMENT CAN NOTICEABLY ACCELERATE THE SETTING TIME OF MIXED CEMENT. 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 : DEVICE HISTORY REVIEWED: 9039324. 1 UNRELATED NON-CONFORMANCE ON THIS LOT NUMBER. FINAL MICRO AND STERILITY TESTS PASSED. (B)(4) UNITS RELEASED. LOT EXPIRY DATE: 31 DECEMBER 2021. 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

    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.

    Description of Event or Problem · 1

    CEMENT SETTING TOO FAST (7 MINS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658918 DEPUY CMW 3G GENTAMICIN 40G BONE CEMENT : BONE CEMENT MBB DEPUY ORTHOPAEDICS, INC. 1818910 9039324

    Patients

    Seq Age Sex Outcome Treatment
    1