BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASPHERE M SPEC 12/14 44 +1.5

    MDR report key: 1990793 · Received February 8, 2011

    Report

    Report Number
    1818910-2011-01904
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    January 9, 2011
    Report Date
    January 9, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWA
    PMA / PMN Number
    K082585
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 REVISED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASPHERE M SPEC 12/14 44 +1.5 KWA, JDI, LPH KWA DEPUY ORTHOPAEDICS, INC. NA 2978196

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention