BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY CMW 2 20G

    MDR report key: 8707066 · Received June 18, 2019

    Report

    Report Number
    1818910-2019-96156
    Event Type
    Injury
    Date Received
    June 18, 2019
    Date of Event
    May 22, 2019
    Report Date
    May 29, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 181891
    Product Code
    LOD
    UDI-DI
    10603295168621
    PMA / PMN Number
    K053003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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. H10 ADDITIONAL NARRATIVE: PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: THE COMPLAINT STATES: ¿REPORTED CIRCULATION FAILURE DURING IMPLANTATION OF IMPLANTS. PATIENT IS STABILIZED. HOSPITAL CONFIRMED THE THIS IS A REPORTABLE ADVERSE EVENT AND WILL REPORT IT TO THE HA.¿ NO LOT IDENTIFICATION OR SAMPLE OF THE PRODUCT SUPPLIED FOR INVESTIGATION. NO TESTING OF RETAINED SAMPLES CAN BE COMPLETED. DVA-107020-FDE REV 8 WAS REVIEWED FOR THIS HAZARD, AND IT IS INCLUDED ON LINES 36, 37, 38, 39, 76, 83, 171 (SEE ATTACHMENT ¿PC(B)(4) EXTRACT FROM DVA-107020-FDE.PDF¿). IN EACH CASE, THE RISK IS CONSIDERED ¿AS LOW AS POSSIBLE¿ AND CANNOT BE FURTHER MITIGATED. THE IFU WAS REVIEWED, AND ADVERSE EVENTS OF THIS NATURE ARE INCLUDED IN THE ¿ADVERSE EVENTS¿ AND ¿WARNINGS¿ SECTIONS (SEE ATTACHMENT (B)(4) EXTRACT FROM IFU-0630003.PDF¿). 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 CANNOT BE REVIEWED AS NO LOT IDENTIFICATION DETAILS SUPPLIED. DEVICE HISTORY BATCH: NULL. DEVICE HISTORY REVIEW: NULL. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). INVESTIGATION SUMMARY : THE COMPLAINT STATES: ¿REPORTED CIRCULATION FAILURE DURING IMPLANTATION OF IMPLANTS. PATIENT IS STABILIZED. HOSPITAL CONFIRMED THE THIS IS A REPORTABLE ADVERSE EVENT AND WILL REPORT IT TO THE HA.¿ NO LOT IDENTIFICATION OR SAMPLE OF THE PRODUCT SUPPLIED FOR INVESTIGATION. NO TESTING OF RETAINED SAMPLES CAN BE COMPLETED. DVA-107020-FDE REV 8 WAS REVIEWED FOR THIS HAZARD, AND IT IS INCLUDED ON LINES 36, 37, 38, 39, 76, 83, 171 (SEE ATTACHMENT ¿(B)(4). EXTRACT FROM DVA-107020-FDE.PDF¿). IN EACH CASE, THE RISK IS CONSIDERED ¿AS LOW AS POSSIBLE¿ AND CANNOT BE FURTHER MITIGATED. THE IFU WAS REVIEWED, AND ADVERSE EVENTS OF THIS NATURE ARE INCLUDED IN THE ¿ADVERSE EVENTS¿ AND ¿WARNINGS¿ SECTIONS (SEE ATTACHMENT (B)(4). EXTRACT FROM IFU-0630003.PDF¿). **NOTIFICATION OF THE LOT NUMBER (9005020) WAS RECEIVED ON 19 SEPTEMBER 2019, ENABLING TESTING OF RETAINED SAMPLES (SEE ATTACHMENT ¿(B)(4). RETEST RESULTS.PDF¿. 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 CEMENT SAMPLES WERE TESTED FOR TM-T150 DOUGH TIME MEAN RESULT: 44S. TM-T150 SETTING TIME MEAN RESULT: 4M 48S. TM-T062 BENZOYL PEROXIDE CONTENT: 2.2164% W/W. TM-T220 DETERMINATION OF TOTAL MONOMER: 1.145% DMPT. TM-T179 IR SCAN LIQUIDS - PASS . TM-T109 IR SCAN POWDERS ¿ PASS. ALL RESULTS ARE WITHIN SPECIFICATION TO MS-002 REV 27. THIS TESTING DOES NOT CHANGE THE CONCLUSION OF THE INVESTIGATION. 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.

    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.

    Description of Event or Problem · 1

    REPORTED CIRCULATION FAILURE DURING IMPLANTATION OF IMPLANTS. DURING THE IMPLANTATION OF TEP HIP RIGHT-SIDE IMPLANT, IN PROCESS OF CEMENTATION AND INSERTION OF THE STEM INTO THE FEMORAL DIAPHYSIS - CARDIAC ARREST OCCURED. THE PATIENT WAS IMMEDIATELY RESUSCITATED, ADRENALIN GIVEN, AND SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT IS STABILIZED. HOSPITAL CONFIRMED THE THIS IS A REPORTABLE ADVERSE EVENT AND WILL REPORT IT TO THE HA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501440 DEPUY CMW 2 20G BONE CEMENT : BONE CEMENT LOD DEPUY ORTHOPAEDICS, INC. 181891 9005020 10603295168621

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention