BEUDAMED
    FDA Adverse Event Death Summary report: N

    VMP ENDURANCE 80G

    MDR report key: 8132990 · Received December 5, 2018

    Report

    Report Number
    1818910-2018-77217
    Event Type
    Death
    Date Received
    December 5, 2018
    Date of Event
    March 5, 2018
    Report Date
    November 7, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LOD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: 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: 0 NON-CONFORMANCES ON THIS LOT NUMBER. FINAL MICRO AND STERILITY TESTS PASSED. COMPLAINTS DATABASE SEARCHED: A COMPLAINT DATABASE SEARCH ON THE PROVIDED LOT NUMBER FOUND 1 ADDITIONAL REPORTS, HOWEVER IT DOES NOT RELATE TO A CARDIOVASCULAR EVENT. TOTAL FOR LOT NUMBER: 2 ((B)(4)). COMPLAINTS RECEIVED BY CMW IN THE LAST 12 MONTHS FOR THIS ISSUE ¿ BY PRODUCT CODE: 1 . BY PRODUCT FAMILY: 2X VACU-MIX PLUS ENDURANCE (1X 50G, 1X 80G). DEVICE HISTORY BATCH: NULL. DEVICE HISTORY REVIEW: NULL. 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

    PATIENT¿S CONDITION WAS ABRUPTLY CHANGED WHEN THE SURGEON INSERTED THE STEM AND CEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    973131 VMP ENDURANCE 80G BONE CEMENT : BONE CEMENT LOD DEPUY ORTHOPAEDICS, INC. 1818910 8513348

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death