BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET HV 20G

    MDR report key: 3852055 · Received June 5, 2014

    Report

    Report Number
    1818910-2014-20316
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 15, 2014
    Manufacturer
    DEPUY CMW-9610921
    Product Code
    LOD
    PMA / PMN Number
    PK023012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE LOT CODES REQUIRED WERE NOT PROVIDED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A. NO ADDITIONAL INFORMATION WAS OBTAINED. PROVIDED INFORMATION STATES THE ASSISTANT NOTICED THE UNI TIBIAL TRAY WAS NOT FULLY SEATED TO THE BONE, THERE WAS A VOID BETWEEN THE CEMENT AND BONE. PROVIDED INFORMATION STATES THIS WAS A TECHNIQUE ISSUE AND NOT A PRODUCT ISSUE. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. 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 SURGERY THE TRAY WAS NOT FULLY SEATED TO THE BONE CAUSING A VOID BETWEEN THE CEMENT AND BONE DUE TO A TECHNIQUE ISSUE, THIS CAUSED A 45 MINUTE EXTENSION TO THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329750 SMARTSET HV 20G CEMENT / CEMENT ACCESSORY LOD DEPUY CMW-9610921 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention