BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SROM STM ST, 36+8L NK, 18X13X160

    MDR report key: 1905326 · Received November 18, 2010

    Report

    Report Number
    1818910-2010-08447
    Event Type
    Injury
    Date Received
    November 18, 2010
    Date of Event
    October 19, 2010
    Report Date
    March 25, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    MRA
    PMA / PMN Number
    K851422
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS GENERAL HIP PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SROM STM ST, 36+8L NK, 18X13X160 87MRA MRA DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Required Intervention