BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 10 X3 INSERT 36MM ID

    MDR report key: 2006241 · Received February 23, 2011

    Report

    Report Number
    2249697-2011-00215
    Event Type
    Injury
    Date Received
    February 23, 2011
    Date of Event
    January 28, 2011
    Report Date
    January 30, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K033716
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. IF ADD'L INFO BECOMES AVAILABLE THEN IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT. CAT# 06-3600, LOT # 53837, DESCRIPTION: C-TAPER COCR LFIT HEAD 36MM/0. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S INFECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE PT HAD INFECTION IN HIP. FEMORAL HEAD AND LINER EXCHANGED WITH NEW. DEBRIDEMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT 10 X3 INSERT 36MM ID IMPLANT LPH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other| R