BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ACCOLADE STEM

    MDR report key: 2232473 · Received August 25, 2011

    Report

    Report Number
    9616680-2011-00558
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 2, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K994366
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE PATIENT FELL RESULTING IN A PERIPROSTHETIC FEMUR FRACTURE WHICH NECESSITATED A REVISION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN ACCOLADE STEM IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 35762403

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention