BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALUMINA C-TAPER HEAD 36MM/0

    MDR report key: 1061661 · Received June 17, 2008

    Report

    Report Number
    9616680-2008-00156
    Event Type
    Injury
    Date Received
    June 17, 2008
    Date of Event
    May 19, 2008
    Report Date
    May 20, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    LZO
    PMA / PMN Number
    K971409
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED: "NOTICED THE CERAMIC HEAD BROKE." REVISION SURGERY WAS REQUIRED TO REPLACE THE BROKEN COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALUMINA C-TAPER HEAD 36MM/0 IMPLANT LZO STRYKER ORTHOPAEDICS CORK NA 9814901

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention