BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0 CROSSFIRE INSERT 28 MM ID

    MDR report key: 1150529 · Received September 5, 2008

    Report

    Report Number
    9616680-2008-00270
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    August 7, 2008
    Report Date
    August 7, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    KWY
    PMA / PMN Number
    K021911
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. MEDICAL RECORDS AND X-RAYS WERE NOT PROVIDED TO STRYKER FOR REVIEW, DUE TO IRB CONSTRAINTS AT OUR INSTITUTION. RETAINED AT DREXEL IMPLANT. NO EVALUATION WILL BE PERFORMED. IF DEVICE BECOMES AVAILABLE WITH ADDITIONAL INFORMATION A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THE ARTHROPLASTY WAS REVISED, DUE TO SUBLUXATION, IMPINGEMENT, AND CUP MALPOSITIONING. THE ACETABULAR COMPONENTS AND FEMORAL HEAD WERE REVISED. THE COMPONENTS WERE IMPLANTED IN SITU FOR 5.21 Y. THE PATIENT PRESENTED A UCLA SCORE OF 4 THREE MONTHS PRIOR TO REVISION SURGERY AND A MAXIMUM FACILITY SCORE OF 4 SINCE IMPLANTATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT 0 CROSSFIRE INSERT 28 MM ID IMPLANT KWY STRYKER ORTHOPAEDICS CORK NA 84088301

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention