BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSETGMV ENDURANCE GENT 40G

    MDR report key: 14464551 · Received May 21, 2022

    Report

    Report Number
    1818910-2022-09349
    Event Type
    Malfunction
    Date Received
    May 21, 2022
    Date of Event
    March 5, 2022
    Report Date
    May 20, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). INVESTIGATION SUMMARY: THE DEVICE ASSOCIATED WITH THIS COMPLAINT WAS NOT RETURNED. PHOTO EVIDENCE PROVIDED WERE REVIEWED AND FOUND THE AMPULE BROKEN. THE REPORTED CONDITION WAS CONFIRMED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY REVIEW: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE (3105040/9783761) PRODUCT AND LOT NUMBERS, AND NR-0162095 MENTIONS THAT NR IS BOUND SOLELY TO THE BATCHES THAT WERE LOCATED IN THE CHAMBER AT THE TIME OF INCIDENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE THE SURGERY, OPENED THE PACKING (DID NOT USE), NOTED THE AMPOULE WAS BROKEN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. NO ADVERSE AFFECTS ON THE PATIENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED: WAS THE SEAL BROKEN/STERILE INTEGRITY OF THE PACKAGE BREACHED? THE WATER AGENT IN THE INNER PACKAGE IS DAMAGED AND THE STERILE INTEGRITY HAS BEEN DAMAGED. HOW THE PACKAGING WAS DAMAGED? UNKNOWN CAUSE OF PACKAGE DAMAGE. WHAT WAS THE SPECIFIC TYPE OF DAMAGE SUSTAINED? CEMENT AGENT LEAKAGE DUE TO AMPOULE BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551438 SMARTSETGMV ENDURANCE GENT 40G BONE CEMENT : BONE CEMENT LOD DEPUY ORTHOPAEDICS INC US 9783761

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown