BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY TIBIAL INSERT

    MDR report key: 1911514 · Received November 29, 2010

    Report

    Report Number
    1818910-2010-09240
    Event Type
    Injury
    Date Received
    November 29, 2010
    Date of Event
    November 3, 2010
    Report Date
    November 3, 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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. 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 POLYETHYLENE WEAR WITHOUT THE PRODUCT TO EXAMINE. IT WAS NOTED THE PRODUCT WAS IMPLANTED FOR SIXTEEN YEARS PRIOR TO REVISION. BASED ON THE PERFORMED INVESTIGATION, A NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS POLY WEAR AND INSTABILITY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention