BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURON NEUT 52OD X 28ID

    MDR report key: 1983565 · Received January 31, 2011

    Report

    Report Number
    1818910-2011-01295
    Event Type
    Injury
    Date Received
    January 31, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 5, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    K944538
    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

    THE PT WAS REVISED TO ADDRESS POLY WEAR OF THE LINER AND STEM LOOSENING. IT WAS REPORTED THAT A COMPETITOR'S CEMENT WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURON NEUT 52OD X 28ID 87HRY, HSX, JDB, JDI, KWA LPH DEPUY ORTHOPAEDICS, INC. NA RP7BV1003

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention