BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11MM X 217MM BOWED PLASMA STEMRESTORATION MODULAR

    MDR report key: 1832070 · Received September 8, 2010

    Report

    Report Number
    9616680-2010-00552
    Event Type
    Injury
    Date Received
    September 8, 2010
    Date of Event
    August 24, 2010
    Report Date
    August 24, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    LZO
    PMA / PMN Number
    K013106
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 PERTAINING TO THE DEVICE(S) REFERENCED IN THIS REPORT 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 PRESENTED WITH A PAINFUL HIP. STEM DID NOT INGROW. STEM APPEARED LOOSE WITH ONLY FIBROUS TISSUE INGROWTH."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 11MM X 217MM BOWED PLASMA STEMRESTORATION MODULAR IMPLANT LZO STRYKER ORTHOPAEDICS CORK NA 13602701

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention