BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURON 10D 54OD X 28ID

    MDR report key: 1945322 · Received December 30, 2010

    Report

    Report Number
    1818910-2010-10735
    Event Type
    Injury
    Date Received
    December 30, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 2, 2010
    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

    PT WAS REVISED TO ADDRESS ANTERIOR AND POSTERIOR DISLOCATION. IT WAS REPORTED THAT THE CUP APPEARED TO BE A LITTLE VERTICAL. POLY WEAR AND OSTEOLYSIS WERE ALSO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURON 10D 54OD X 28ID 87HRY LPH DEPUY ORTHOPAEDICS, INC. NA SA5EP1

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention