BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE PLUS TMZF HIP STEM #5

    MDR report key: 2150501 · Received June 23, 2011

    Report

    Report Number
    9616680-2011-00415
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 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
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PATIENT COMPLAINED OF HIP PAIN. STEM DID NOT OSTEOINTERGRATE AND WAS PULLED OUT EASILY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCOLADE PLUS TMZF HIP STEM #5 IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 29166301

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention