BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTIMA COLL STM, 10/12 SZ 1M

    MDR report key: 1903238 · Received November 12, 2010

    Report

    Report Number
    1818910-2010-08008
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 14, 2010
    Manufacturer
    DEPUY-CORK, A DIV. OF DEPUY ORTHOPAEDICS
    Product Code
    KWL
    PMA / PMN Number
    K924379
    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

    PT WAS REVISED TO ADDRESS FEMORAL LOOSENING AND OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTIMA COLL STM, 10/12 SZ 1M 87KWL KWL DEPUY-CORK, A DIV. OF DEPUY ORTHOPAEDICS NA 1096131

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention