BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK PRODUCT

    MDR report key: 1874112 · Received October 14, 2010

    Report

    Report Number
    2249697-2010-01354
    Event Type
    Injury
    Date Received
    October 14, 2010
    Date of Event
    December 14, 2007
    Report Date
    September 21, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    KWZ
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFO PROVIDED BY STRYKER ORTHOPAEDICS' CLINICAL AFFAIRS DEPT. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME. ADDITIONAL F/U INFO MAY BE OBTAINED BY THE CLINICAL AFFAIRS DEPT AS IT BECOMES AVAILABLE. IF ADDITIONAL INFO BECOMES AVAILABLE THEN IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    A CASE ENROLLED IN THE TRIDENT TRITANIUM ACETABULAR SHELL REVISION STUDY (#61) WAS REPORTED TO HAVE HAD PREVIOUS IMPLANTS MFG BY STRYKER. THE COMPONENTS WERE REPORTED TO BE REVISED FOR ASEPTIC LOOSENING AND INFECTION OF THE ACETABULUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK PRODUCT IMPLANT KWZ STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other| R