BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ALUMINA HEAD

    MDR report key: 1032842 · Received April 22, 2008

    Report

    Report Number
    9616680-2008-00100
    Event Type
    Injury
    Date Received
    April 22, 2008
    Date of Event
    March 29, 2008
    Report Date
    March 31, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    NI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, NEITHER THE DEVICE NOR ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PATIENT PRESENTED WITH ALUMINA HEAD AND LINER AND SHATTERED IN THE BODY." REVISION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN ALUMINA HEAD IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention