BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CITATION TMZF HA STEM #3 RIGHT

    MDR report key: 1881201 · Received October 20, 2010

    Report

    Report Number
    9616680-2010-00661
    Event Type
    Injury
    Date Received
    October 20, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 5, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K963127
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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, "ASEPTIC LOOSENING OF THE FEMORAL COMPONENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CITATION TMZF HA STEM #3 RIGHT IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 25671302

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention