BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1984427 · Received January 27, 2011

    Report

    Report Number
    1818910-2011-01132
    Event Type
    Injury
    Date Received
    January 27, 2011
    Report Date
    December 28, 2010
    Manufacturer
    DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS
    Product Code
    JDI
    PMA / PMN Number
    K851422
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    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

    LITIGATION PAPERS ALLEGE THE PT EXPERIENCED THIGH PAIN. IT IS FURTHER ALLEGED THAT DURING A FOLLOW-UP VISIT THE SURGEON OBSERVED THAT THE END OF THE STEM OF HER PROSTHESIS HAD SHIFTED AND WAS PRESSING ON THE CORTEX OF THE FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SROM STM ST, 36+8L NK, 18X13X160 87JDI JDI DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS NA 2938939

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention