BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIDENT 0 DEG INSERT 40MM

    MDR report key: 2212103 · Received July 8, 2011

    Report

    Report Number
    2249697-2011-01014
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 16, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K062419
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT IS STILL IMPLANTED. IF ADDITIONAL INFORMATION IS PROVIDED, THE EVALUATION RESULTS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    TOTAL HIP ARTHROPLASTY, SURGEON CEMENTED A CUP LINER INTO THE ACETABULUM INSTEAD OF A CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT 0 DEG INSERT 40MM IMPLANT JDI STRYKER ORTHOPAEDICS MAHWAH NA MKEEHM

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other