BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0 DEG CROSSFIRE INSERT 36 MM ID

    MDR report key: 2915551 · Received January 10, 2013

    Report

    Report Number
    2249697-2013-90111
    Event Type
    Injury
    Date Received
    January 10, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 18, 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 PRIMARY TRITANIUM HEMI SOLIDBACK CUP 54MM, CAT# 500-03-54E, LOT# MLJMYY 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 REVISION. AN EVAL OF THE REPORTED DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE PT AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFO (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. SHOULD ADDITIONAL INFO BECOME AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT HAD AN OOZING WOUND, SO SURGEON DECIDED TO DO AN I&D/HEAD LINER EXCHANGE. UPON TRYING TO REMOVE THE LINER, THE CUP LOOSENED. SURGEON DECIDED TO MAKE ANTIBIOTIC SPACER OVER THE EXISTING CERAMIC HEAD AND REIMPLANTED. SURGEON WILL WAIT FOR CULTURES TO COME BACK FROM THE LAB AND THEN DECIDE WHAT THE NEXT STEP WILL BE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14419 TRIDENT 0 DEG CROSSFIRE INSERT 36 MM ID IMPLANT LPH STRYKER ORTHOPAEDICS MAHWAH NA MLKXAX

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention