BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTIMA CEM FEM HIP STEM SZ1

    MDR report key: 2163290 · Received July 8, 2011

    Report

    Report Number
    1818910-2011-12350
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 9, 2011
    Manufacturer
    DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS
    Product Code
    JDI
    PMA / PMN Number
    K953202
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, 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.

    Additional Manufacturer Narrative · 1

    (B)(4). EXAMINATION OF THE RETURNED DEVICE FINDS NOTHING OUTWARD TO SUGGEST PRODUCT ERROR. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION IN AUGUST 2004. AS STATED, IT IS NOT KNOWN IF COMPETITOR OR DEPUY CEMENT PRODUCT WAS USED WHEN IMPLANTED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE PT WAS REVISED BECAUSE THE STEM WAS LOOSE AT BOTH INTERFACES. THE MANUFACTURER OF THE CEMENT USED IN THE PRIMARY SURGERY IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTIMA CEM FEM HIP STEM SZ1 87JDI JDI DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS NA 1117501

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention