BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0 DEG INSERT 44MM

    MDR report key: 2233995 · Received August 31, 2011

    Report

    Report Number
    2249697-2011-01291
    Event Type
    Injury
    Date Received
    August 31, 2011
    Date of Event
    August 9, 2011
    Report Date
    August 9, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    MRA
    PMA / PMN Number
    K062419
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT # 06260-9-044, LOT # A4EMTA, DESCRIPTION: V40 COCR LIFT HEAD 44MM/-4. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S INFECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "THE PATIENT APPEARED TO BE INFECTED. THE SURGEON OPENED THE HIP TOOK CULTURES ETC. THEN REMOVED THE HEAD AND LINER-WASHED OUT THE HIP AND THEN REPLACED WITH A NEW HEAD AND LINER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT 0 DEG INSERT 44MM IMPLANT MRA STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other| R