BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CEMENTLESS CUP

    MDR report key: 1903248 · Received November 12, 2010

    Report

    Report Number
    1818910-2010-07971
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 14, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDI
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 HAD A TOTAL HIP REPLACEMENT A NUMBER OF YEARS AGO. THE PT HAS PRESENTED WITH A PAINFUL HIP ALONG WITH CONSIDERABLE LEG LENGTH DISCREPANCY. IT IS UNK WHETHER THE LEG LENGTH SHORTENING ON THE OPERATED SIDE HAS BEEN LONG TERM. THE ACETABULAR CUP WAS WELL FIXED AND REQUIRED SUBSTANTIAL EFFORT TO REMOVE. THE S ROM FEMORAL STEM WAS REMOVED LEAVING THE ORIGINAL PROXIMAL SLEEVE IN SITU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CEMENTLESS CUP TOTAL HIP REPLACEMENT JDI DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention