BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRODIGY SM STAT SHT RT 10.5MM

    MDR report key: 1365022 · Received April 14, 2009

    Report

    Report Number
    1818910-2009-01712
    Event Type
    Other
    Date Received
    April 14, 2009
    Report Date
    March 20, 2009
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    K931641
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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

    X-RAYS SHOW STEM FRACTURE. NO REVISION SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRODIGY SM STAT SHT RT 10.5MM 87LPH LPH DEPUY ORTHOPAEDICS, INC. NA AR2AA1000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other