BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM SLEEVE PRX SPA, 14B

    MDR report key: 1920048 · Received December 3, 2010

    Report

    Report Number
    1818910-2010-09274
    Event Type
    Injury
    Date Received
    December 3, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 4, 2010
    Manufacturer
    DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS
    Product Code
    MRA
    PMA / PMN Number
    P040023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 WAS REVISED TO ADDRESS FEMORAL LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S-ROM SLEEVE PRX SPA, 14B 87MRA MRA DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS NA 2611699

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention