BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0 CROSSFIRE INSERT 36 MM ID

    MDR report key: 2705827 · Received August 13, 2012

    Report

    Report Number
    2249697-2012-01178
    Event Type
    Injury
    Date Received
    August 13, 2012
    Date of Event
    July 24, 2012
    Report Date
    July 24, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K021911
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER HIP DEVICES WERE ALSO LISTED IN THIS REPORT. C-TAPER COCR LFIT HEAD 36MM/+10, CAT# 06-3610, LOT# 21342401. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S INFECTION. AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE PT AND WAS NOT RETURNED TO THE MFR. ADD'L INFO PERTAINING TO THE DEVICE REFERENCED IN THIS REPORT (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. SHOULD ADD'L INFO BECOME AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, SURGEON PERFORMED A HEAD/LINER EXCHANGE DUE TO POSSIBLE INFECTION. REVISED 36 MM + 10 HEAD AND 36 MM LINER TO A CONSTRAINED E LINER WITH A 22MM + 10 HEAD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention