BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY DURALOC 54X28MM LINER

    MDR report key: 2020135 · Received March 11, 2011

    Report

    Report Number
    1818910-2011-04026
    Event Type
    Injury
    Date Received
    March 11, 2011
    Date of Event
    February 10, 2011
    Report Date
    February 10, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWA
    PMA / PMN Number
    NA
    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 A LOOSE CUP AND PAIN IN HIP. POLY WEAR OF THE LINER WAS ALSO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY DURALOC 54X28MM LINER TOTAL HIP PROSTHESIS KWA DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention