BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORATION ADM X3 INS 28/58

    MDR report key: 1881173 · Received October 20, 2010

    Report

    Report Number
    9616680-2010-00656
    Event Type
    Injury
    Date Received
    October 20, 2010
    Date of Event
    September 23, 2010
    Report Date
    September 30, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K093644
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 REVISION DUE TO THE HEAD DISLOCATED FROM THE LINER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORATION ADM X3 INS 28/58 IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 33633601

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention