BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0 X 3 INSERT 36MM ID

    MDR report key: 2562748 · Received May 2, 2012

    Report

    Report Number
    2249697-2012-00548
    Event Type
    Injury
    Date Received
    May 2, 2012
    Date of Event
    April 20, 2012
    Report Date
    April 20, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K033716
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER HIP DEVICE WAS ALSO LISTED IN THIS REPORT: C-TAPER COCR LFIT HEAD 36MM/0, CAT# 06-3600, LOT #MLDLD9. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S INFECTION. ADDITIONAL INFO (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED, I & D DUE TO INFECTION AND REMOVED THE POLY. THE SURGEON NOTED UNUSUAL WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT 0 X 3 INSERT 36MM ID IMPLANT LPH STRYKER ORTHOPAEDICS MAHWAH NA MKTYP5

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention