BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0 X3 INSERT 36MM ID

    MDR report key: 1080430 · Received July 21, 2008

    Report

    Report Number
    2249697-2008-00211
    Event Type
    Injury
    Date Received
    July 21, 2008
    Date of Event
    June 16, 2008
    Report Date
    June 24, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K033716
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS DISCARDED AND WILL NOT BE RETURNED. NO EVAL WILL BE PERFORMED. IF DEVICE BECOMES AVAILABLE WITH ADD'L INFO, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE ABOVE ACETABULAR INSERT THAT WAS LOOSELY CEMENTED IN PLACE AS AN INFECTION SPACER WAS REMOVED ALONG WITH THE CEMENT. A NEW ACETABULAR INSERT 623-00-36H (LOT 29862401) WAS CEMENTED IN LOOSELY WITH PALACOS CEMENT MIXER WITH ANTIBIOTICS. THE FEMUR WAS FRACTURED AT THE DISTAL END OF THE CONICAL STEM ABOVE. THE CONICAL STEM WAS EXPLANTED AND SEPARATED FROM THE MT3 PROXIMAL BODY. A RESTORATION MODULAR FLUTED DISTAL STEM 17X267MM BOWED WAS IMPLANTED AND THE PREVIOUSLY USED MT3 PROXIMAL BODY AND 36MM BODY WERE ATTACHED. THE SURGEON TIGHTENED THE SCREW WITH THE 5MM BOLT ATTACHED TO THE T-HANDLE AND THE HEAD OF THE SCREW BROKE OFF."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT 0 X3 INSERT 36MM ID IMPLANT MEH STRYKER ORTHOPAEDICS MAHWAH NA 4R6MAE

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention