BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSTRAINED ACETABULAR INSERTS

    MDR report key: 1150524 · Received September 5, 2008

    Report

    Report Number
    2249697-2008-00250
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    August 1, 2008
    Report Date
    August 5, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    KWB
    PMA / PMN Number
    K890197
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT AVAILABLE FOR EVALUATION. NO EVALUATION WILL BE PERFORMED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS WALKING AND THE INNER BI-POLAR COMPONENT TWISTED AND LOCATED FROM THE OUTER LINER WHICH REMAINED WELL-LOCKED POSTERIORLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSTRAINED ACETABULAR INSERTS IMPLANT KWB STRYKER ORTHOPAEDICS MAHWAH NA EL7MJD

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention