BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROLOC CONST LINER 60/72X32

    MDR report key: 1822658 · Received August 27, 2010

    Report

    Report Number
    1818910-2010-05819
    Event Type
    Injury
    Date Received
    August 27, 2010
    Date of Event
    July 30, 2010
    Report Date
    July 30, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDI
    PMA / PMN Number
    P960054/S02
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 BECAUSE THE LOCKING RING DISASSOCIATED FROM THE LINER AND THE PT DISLOCATED. IT WAS REPORTED THAT THE PT HAD NO ABDUCTOR MUSCLES. IT WAS ALSO NOTED THAT THE ARDS ON THE NEW LINER WERE BENT DURING IMPACTION; HOWEVER, THE SURGEON BENT THEM BACK INTO SHAPE AND IMPLANTED THE LINER SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUROLOC CONST LINER 60/72X32 87JDI JDI DEPUY ORTHOPAEDICS, INC. NA BK2CG1000

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention