BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEFINITION PM CEMENTED HIP #3

    MDR report key: 1971512 · Received January 20, 2011

    Report

    Report Number
    9616680-2011-00025
    Event Type
    Injury
    Date Received
    January 20, 2011
    Date of Event
    January 3, 2011
    Report Date
    January 3, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    JDI
    PMA / PMN Number
    K936127
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PT WAS BROUGHT TO OPERATING ROOM WITH POSSIBLE INFECTED HIP. IMPLANTS WERE REMOVED AND AN ANTIBIOTIC SPACER PUT IN PLACE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEFINITION PM CEMENTED HIP #3 IMPLANT JDI STRYKER ORTHOPAEDICS CORK NA 1370108

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention