BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVANTE STRGHT PRFIT TMZF MOD STEM SIZE 8

    MDR report key: 2911066 · Received January 4, 2013

    Report

    Report Number
    2249697-2013-90043
    Event Type
    Injury
    Date Received
    January 4, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 13, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    KWL
    PMA / PMN Number
    K092561
    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 DUE TO HOSPITAL POLICY. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAS HIP PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4329 REJUVANTE STRGHT PRFIT TMZF MOD STEM SIZE 8 IMPLANT KWL STRYKER ORTHOPAEDICS MAHWAH NA MKKM4V

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention