BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0 DEG CONSTRAINED INSERT 28G

    MDR report key: 911578 · Received September 12, 2007

    Report

    Report Number
    2249697-2007-00126
    Event Type
    Injury
    Date Received
    September 12, 2007
    Date of Event
    August 10, 2007
    Report Date
    August 14, 2007
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    KWY
    PMA / PMN Number
    K061654
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION, HAS BEEN REQUESTED AND IF RECEIVED, WILL BE REPORTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE BIPOLAR IMPLANT DISLOCATED FROM THE CONSTRAINED LINER." PATIENT WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT 0 DEG CONSTRAINED INSERT 28G IMPLANT KWY STRYKER ORTHOPAEDICS MAHWAH NA 161MED

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention