BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT HEMISPHERICAL SOLID BK 56MM

    MDR report key: 2090848 · Received May 12, 2011

    Report

    Report Number
    9616680-2011-00294
    Event Type
    Injury
    Date Received
    May 12, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 25, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K013676
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 WAS REQUESTED. IF IT 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 # 06-3605, LOT # TDNMNE, DESCRIPTION: C-TAPER COCR LFIT HEAD 36MM/+5. CAT # 623-10-36F, LOT # 51AMMD, DESCRIPTION: TRIDENT 10 X3 INSERT 36MM ID. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "PATIENT WAS REVISED DUE TO FAILED TOTAL HIP ARTHROPLASTY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT HEMISPHERICAL SOLID BK 56MM IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 28542401

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention