BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VMP ENDURANCE 50G

    MDR report key: 10208713 · Received June 29, 2020

    Report

    Report Number
    1818910-2020-14621
    Event Type
    Malfunction
    Date Received
    June 29, 2020
    Date of Event
    June 17, 2020
    Report Date
    June 16, 2020
    Manufacturer
    DEPUY CMW - 9610921
    Product Code
    LOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : THE COMPLAINT STATES: "THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2020 VIA TSA (WITH ANOTHER COMPANY\2019S IMPLANTS). DURING THE SURGERY, WHEN THE SURGEON OPENED THE PACKAGE OF THE CEMENT (P/N: 3172050), THERE WAS 2 MONOMER AMPULES IN THE PACKAGE. THE SURGEON MIXED THE MONOMER WITH POLYMER POWDER, HE FELT ABNORMAL SOFTNESS AND STOPPED TO USE THE CEMENT. THE SURGERY WAS COMPLETED WITH ANOTHER CEMENT (VACU-MIX PLUS, P/N: UNKNOWN) WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION WAS AVAILABLE." THE PRODUCT WAS NOT RETURNED FOR EXAMINATION, AND THE COMPLAINT DESCRIPTION CANNOT BE CONFIRMED. AS PER THE SPECIFICATION MS-022, PRODUCT CODE 3172050 SHOULD ONLY INCLUDE 1 MONOMER AMPOULE. THE USE OF A SECOND AMPOULE DURING THE MIXING OF THE CEMENT WOULD RESULT IN A SOFTER MIX AS REPORTED IN THE COMPLAINT DESCRIPTION. THE MANUFACTURING PROCESS MPS-C-22 APPENDIX 1, STEP 9 CHECKS TO CONFIRM THAT THE CORRECT NUMBER OF AMPOULES ARE AVAILABLE DEPENDING ON THE PRODUCT CODE. STEP 17 EXPLAINS THE WEIGHT CHECK AND TOLERANCE FOR THE COMPLETE PACKED UNIT (±10G). THE WEIGHT OF A SINGLE AMPOULE FOR THE PRODUCT CODE REPORTED IN THIS COMPLAINT IS 23.60G: THE INCLUSION OF A SECOND AMPOULE WOULD TRIGGER THE OUT OF TOLERANCE ACTIONS BY THE FINAL PACK TEAM. MPS-C-22 INCLUDES THE STATEMENT THAT ¿UNIT CARTONS THAT ARE OUT OF TOLERANCE SHALL BE OPENED, CONTENTS REMOVED AND INSPECTED AS PER (B)(4).¿ NO RECONCILIATION ISSUES WERE REPORTED ON THE FINAL PACK DEVICE HISTORY SHEET FOR THIS LOT NUMBER. IFU-0630167 WAS REVIEWED AND INCLUDES CONFIRMATION THAT THE 50G PACK SHOULD ONLY INCLUDE 1 MONOMER AMPOULE IN THE ¿PRESENTATION¿ AND ¿PACKAGE QUANTITIES¿ SECTIONS. RETAINED SAMPLES FOR THIS LOT NUMBER WERE CHECKED AND NO UNITS INCLUDED A SECOND AMPOULE. IN CONCLUSION, THE ADDITION OF A SECOND AMPOULE DURING THE MIXING FOR THIS PRODUCT CODE WOULD RESULT IN A SOFTER MIX AS REPORTED. THE ROOT CAUSE FOR THIS COMPLAINT CANNOT BE DETERMINED BASED ON THE INFORMATION AVAILABLE. 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 : 2 UNRELATED NON CONFORMANCES ON THIS LOT NUMBER. FINAL MICRO AND STERILITY TESTS PASSED. (B)(4) RELEASED. LOT EXPIRY DATE: 31-MAY-21.

    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

    DURING THE SURGERY, WHEN THE SURGEON OPENED THE PACKAGE OF THE CEMENT (P/N: 3172050), THERE WAS 2 MONOMER AMPULES IN THE PACKAGE. THE SURGEON MIXED THE MONOMER WITH POLYMER POWDER, HE FELT ABNORMAL SOFTNESS AND STOPPED TO USE THE CEMENT. THE SURGERY WAS COMPLETED WITH ANOTHER CEMENT (VACU-MIX PLUS, P/N: UNKNOWN) WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673679 VMP ENDURANCE 50G BONE CEMENT : BONE CEMENT LOD DEPUY CMW - 9610921 9174148

    Patients

    Seq Age Sex Outcome Treatment
    1 VMP ENDURANCE 50G