BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LPS TIB HINGE INSERT SM 18MM

    MDR report key: 1080111 · Received July 18, 2008

    Report

    Report Number
    1818910-2008-02704
    Event Type
    Injury
    Date Received
    July 18, 2008
    Date of Event
    June 18, 2008
    Report Date
    June 18, 2008
    Manufacturer
    DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.
    Product Code
    KRO
    PMA / PMN Number
    K011810
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    THE PT WAS REVISED BECAUSE OF A FRACTURED INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LPS TIB HINGE INSERT SM 18MM 87KRO KRO DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC. NA ZW5J84000

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention