BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIFIT COLLARLESS STEM COCR MOLD#147

    MDR report key: 1032844 · Received April 22, 2008

    Report

    Report Number
    2249697-2008-00097
    Event Type
    Injury
    Date Received
    April 22, 2008
    Date of Event
    March 25, 2008
    Report Date
    March 25, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    KWY
    PMA / PMN Number
    K844818
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    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, "STEM AND ACETABULAR SHELL WERE LOOSE. REPLACED STEM USING RESTORATION MODULAR AND V40 HEAD. USED ZIMMER TO REPLACE SHELL AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIFIT COLLARLESS STEM COCR MOLD#147 IMPLANT KWY STRYKER ORTHOPAEDICS MAHWAH NA 7W548

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention