BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE TMZF HIP STEM #7

    MDR report key: 1855135 · Received September 30, 2010

    Report

    Report Number
    9616680-2010-00608
    Event Type
    Injury
    Date Received
    September 30, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 13, 2010
    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
    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: "STEM SUBSIDED - CRACK IN THE FEMUR. PERIPROSTHETIC FRACTURE. TOOK OUT TMZF STEM CABLED THE FEMUR. CEMENTED A LONG STEM HIP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCOLADE TMZF HIP STEM #7 IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 16007001

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention