BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY SIGMA TIBIAL INSERT

    MDR report key: 1914202 · Received December 1, 2010

    Report

    Report Number
    1818910-2010-09316
    Event Type
    Injury
    Date Received
    December 1, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 5, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED. THE PRODUCT CODE AND LOT CODE REQUIRED IN RETRIEVING THE DEVICE HISTORY RECORDS FOR REVIEWING AND SEARCHING THE COMPLAINT DATABASE WERE NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED INFECTION BASED ON THE PROVIDED INFO. PROVIDED INFO STATED THE PRODUCT WAS NOT SUSPECTED OF FAILING TO MEET SPECIFICATIONS OR BEING A CONTRIBUTING FACTOR TO THE EVENT. BASED ON THE PERFORMED INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFO BE RECEIVED, THE INVESTIGATION WILL BEE RE-OPENED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY SIGMA TIBIAL INSERT TOTAL KNEE PROTHESIS JWH DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention