BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTIMA CALCAR STD LGT, SZ4 55MM

    MDR report key: 1213949 · Received October 27, 2008

    Report

    Report Number
    1818910-2008-04761
    Event Type
    Injury
    Date Received
    October 27, 2008
    Date of Event
    September 30, 2008
    Report Date
    September 30, 2008
    Manufacturer
    DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS
    Product Code
    JDI
    PMA / PMN Number
    K964795
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE DEVICES WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT CODES SINCE THEIR RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT ERROR WITH REGARD TO THE REPORTED EVENT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Description of Event or Problem · 1

    THE PT WAS REVISED BECAUSE OF A PERIPROSTHETIC FRACTURE, INFECTION AND THE STEM LOOSENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTIMA CALCAR STD LGT, SZ4 55MM 87JDI JDI DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS NA 2090272

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention