BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LPS TIB HINGE INSERT XSM 28MM

    MDR report key: 1242650 · Received November 20, 2008

    Report

    Report Number
    1818910-2008-05492
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    October 21, 2008
    Report Date
    October 21, 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
    GA, 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

    PATIENT WAS REVISED TO ADDRESS INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LPS TIB HINGE INSERT XSM 28MM 87KRO KRO DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC. NA BE7DS4000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention