BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 10 X 3 INSERT 36MM ID

    MDR report key: 1619121 · Received February 24, 2010

    Report

    Report Number
    2249697-2010-00216
    Event Type
    Injury
    Date Received
    February 24, 2010
    Date of Event
    January 28, 2010
    Report Date
    January 28, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K033716
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE C-TAPER COCR LFIT HEAD 36MM/+10: CAT 06-3610; LOT R74MRD WAS ALSO LISTED IN THIS REPORT. IT CANNOT BE DETERMINED WHICH, IF ANY OF THE REPORTED DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S INFECTION. AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE HOSP KEEPS ALL IMPLANTS, AND THEY WERE NOT RETURNED TO THE MFR. ADDITIONAL INFO INCLUDING X-RAYS AND MEDICAL RECORDS WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "INFECTED HIP. INSERT AND HEAD EXCHANGED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT 10 X 3 INSERT 36MM ID IMPLANT LPH STRYKER ORTHOPAEDICS MAHWAH NA MHT3JJ

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention