BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11/13 S-ROM 40MM M SPEC + 0

    MDR report key: 1905414 · Received November 19, 2010

    Report

    Report Number
    1818910-2010-08589
    Event Type
    Injury
    Date Received
    November 19, 2010
    Date of Event
    October 22, 2010
    Report Date
    October 22, 2010
    Manufacturer
    DEPUY INTL., LTD.
    Product Code
    LPH
    PMA / PMN Number
    K060031
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 REVISED FOR INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 11/13 S-ROM 40MM M SPEC + 0 87 LPH, JDI LPH DEPUY INTL., LTD. NA 2992147

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention