BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX50OD

    MDR report key: 1180144 · Received September 26, 2008

    Report

    Report Number
    1818910-2008-04038
    Event Type
    Injury
    Date Received
    September 26, 2008
    Date of Event
    August 28, 2008
    Report Date
    August 28, 2008
    Manufacturer
    DEPUY INTERNATIONAL, LTD
    Product Code
    KWA
    PMA / PMN Number
    K073504
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    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 DISLOCATION (RIGHT SIDE). THIS PT HAD PREVIOUSLY UNDERGONE A HEMI-PELVECTOMY AND HAS ONLY ONE LEG. THE DISLOCATION OCCURRED ON THE SIDE WITH THE LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE MTL INS NEUT36IDX50OD 87KWA KWA DEPUY INTERNATIONAL, LTD NA 2597155

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention