BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURALOC CONST LINER 58/70X28

    MDR report key: 1972482 · Received January 26, 2011

    Report

    Report Number
    1818910-2011-00998
    Event Type
    Injury
    Date Received
    January 26, 2011
    Date of Event
    December 27, 2010
    Report Date
    December 27, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    P960054/S02
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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

    PT REVISED FOR DISLOCATION. LOCKING RING POPPED OUT CAUSING DISLOCATION. LOOSENING ALSO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURALOC CONST LINER 58/70X28 NA LPH DEPUY ORTHOPAEDICS, INC. NA AC8AT1

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention