BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRSVN ALLPOLY TIB LMRL S2 7MM

    MDR report key: 1212631 · Received October 24, 2008

    Report

    Report Number
    1818910-2008-04550
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    September 25, 2008
    Report Date
    September 25, 2008
    Manufacturer
    DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.
    Product Code
    HRY
    PMA / PMN Number
    K010810
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 PAIN. SURGEON NOTED LOOSENING OF THE TIBIAL TRAY UPON ENTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRSVN ALLPOLY TIB LMRL S2 7MM 87HRY HRY DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC. NA BW7J64000

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention