BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM STM STD,36NK,16X11X150

    MDR report key: 1895034 · Received November 5, 2010

    Report

    Report Number
    1818910-2010-08093
    Event Type
    Injury
    Date Received
    November 5, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 8, 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
    OTHER

    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 DISASSOCIATION OF THE LINER FROM THE CUP, A BROKEN STEM, AND A LOOSE SLEEVE WITH LACK OF INGROWTH. POLY WEAR OF THE LINER WAS ALSO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S-ROM STM STD,36NK,16X11X150 87JDI JDI DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS NA 743510

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention