BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT BASIC PRESS FIT SZ 2

    MDR report key: 1071247 · Received July 7, 2008

    Report

    Report Number
    1818910-2008-02577
    Event Type
    Injury
    Date Received
    July 7, 2008
    Date of Event
    June 10, 2008
    Report Date
    June 10, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LWJ
    PMA / PMN Number
    K030122
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFO BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS DISASSOCIATION OF THE HEAD AND LOOSENING OF THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUMMIT BASIC PRESS FIT SZ 2 87LWJ LWJ DEPUY ORTHOPAEDICS, INC. NA XS9BP1007

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention