BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PRODUCT - ALUMINA CERAMIC HEAD 32MM - 4

    MDR report key: 1844652 · Received September 20, 2010

    Report

    Report Number
    9616680-2010-00590
    Event Type
    Injury
    Date Received
    September 20, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 7, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MRA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PT. HAD FALLEN AND FRACTURED THE HEAD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN PRODUCT - ALUMINA CERAMIC HEAD 32MM - 4 IMPLANT MRA STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention