BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11/13 S-ROM 44MM M SPEC+9

    MDR report key: 1933587 · Received December 17, 2010

    Report

    Report Number
    1818910-2010-10141
    Event Type
    Injury
    Date Received
    December 17, 2010
    Date of Event
    November 19, 2010
    Report Date
    November 19, 2010
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    LPH
    PMA / PMN Number
    K060031
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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

    PT WAS REVISED TO ADDRESS POSSIBLE METAL SENSITIVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 11/13 S-ROM 44MM M SPEC+9 87LPH; 87JDI LPH DEPUY INTERNATIONAL, LTD. NA 2377338

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Male Required Intervention