BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ODC-FX CEMENTED HIP #7

    MDR report key: 1163109 · Received September 16, 2008

    Report

    Report Number
    2249697-2008-00269
    Event Type
    Injury
    Date Received
    September 16, 2008
    Date of Event
    August 19, 2008
    Report Date
    August 19, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    KWY
    PMA / PMN Number
    K913812
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED DUE TO HOSPITAL REFUSAL TO RELEASE IT. NO EVAL WILL BE PERFORMED. SHOULD DEVICE BECOME AVAILABLE WITH ADDITIONAL INFO A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "REVISION PERFORMED DUE TO ASEPTIC LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ODC-FX CEMENTED HIP #7 IMPLANT KWY STRYKER ORTHOPAEDICS MAHWAH NA TPRMEA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention