BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA HP UNI TIB TRAY SZ4 LMRL

    MDR report key: 3851486 · Received June 5, 2014

    Report

    Report Number
    1818910-2014-20283
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 21, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HRY
    PMA / PMN Number
    PK070267
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A. NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS 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.

    Description of Event or Problem · 1

    PATIENT HAS PRESENTED WITH AN UNEXPLAINED TIBIAL PLATEAU FRACTURE THAT HAS RESULTED IN REVISION KNEE SURGERY. SIGMA PARTIAL WAS REVISED TO MBT TRAY WITH SLEEVE AND STEM. THE FEMORAL COMPONENT WAS REVISED TO A SIGMA POSTERIOR STABILISED WITH COMPATIBLE RP INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328688 SIGMA HP UNI TIB TRAY SZ4 LMRL KNEE TIBIAL TRAY HRY DEPUY ORTHOPAEDICS, INC. 296657

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention