BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM SLEEVE PRX ZTT, 20D-LRD

    MDR report key: 1960924 · Received January 11, 2011

    Report

    Report Number
    1818910-2011-00513
    Event Type
    Injury
    Date Received
    January 11, 2011
    Date of Event
    November 29, 2010
    Report Date
    November 29, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, DEPUY-CORK
    Product Code
    MRA
    PMA / PMN Number
    P040023
    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

    PATIENT WAS REVISED TO ADDRESS ASEPTIC LOOSENING OF THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S-ROM SLEEVE PRX ZTT, 20D-LRD 87MRA MRA DEPUY ORTHOPAEDICS, DEPUY-CORK NA 2880640

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention