BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNKNOWN DEPUY S-ROM STEM

    MDR report key: 1941965 · Received December 17, 2010

    Report

    Report Number
    1818910-2010-10043
    Event Type
    Other
    Date Received
    December 17, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 18, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDI
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    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 AND SUBSIDENCE, AS WELL AS METALLOSIS. IT WAS ALSO REPORTED THAT THE PT HAD A FRACTURE OF THE GREATER TROCHANTER AND HAD ALSO HAD FOUR PREVIOUS SURGERIES, ALTHOUGH NO INFO IS AVAILABLE ABOUT THOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY S-ROM STEM TOTAL HIP PROSTHESIS JDI DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention