BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0 DEG INSERT 40MM

    MDR report key: 2171331 · Received July 15, 2011

    Report

    Report Number
    2249697-2011-01059
    Event Type
    Injury
    Date Received
    July 15, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 23, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K061434
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PATIENT'S HIP WAS REVISED FOR ASEPTIC STEM LOOSENING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT 0 DEG INSERT 40MM IMPLANT LPH STRYKER ORTHOPAEDICS MAHWAH NA 1J5MKA

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Other| R