BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE (127 DEG)

    MDR report key: 1181688 · Received September 30, 2008

    Report

    Report Number
    9616680-2008-00301
    Event Type
    Injury
    Date Received
    September 30, 2008
    Date of Event
    January 28, 2008
    Report Date
    September 5, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K994366
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO PERTAINING TO THE EVENT REFERENCED IN THIS REPORT WAS REQUESTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT HAD A REVISION SURGERY IN 2008. PRIMARY STEM WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCOLADE (127 DEG) IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 25007601

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention