BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM STM ST 36+ 12L 19X24X175

    MDR report key: 1885145 · Received October 22, 2010

    Report

    Report Number
    1818910-2010-07485
    Event Type
    Injury
    Date Received
    October 22, 2010
    Date of Event
    September 25, 2010
    Report Date
    September 25, 2010
    Manufacturer
    DEPUY INTL., LTD.
    Product Code
    KWA
    PMA / PMN Number
    K061221
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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

    PT REVISED FOR INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S-ROM STM ST 36+ 12L 19X24X175 87 KWA, LPH, LZO KWA DEPUY INTL., LTD. NA 2531767

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention