BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PNN MAR +4 NEUT 32IDX50OD

    MDR report key: 1397800 · Received May 28, 2009

    Report

    Report Number
    1818910-2009-02733
    Event Type
    Injury
    Date Received
    May 28, 2009
    Date of Event
    May 6, 2009
    Report Date
    May 6, 2009
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    K033273
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER RELATED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT CODES SINCE THEIR RELEASE FOR DISTRIBUTION. IT IS STATED IN THE INITIAL PRODUCT INVESTIGATION REQUEST, IT WAS NOT SUSPECTED THAT THE DEVICES FAILED TO MEET SPECIFICATIONS OR CONTRIBUTED TO THE REPORTED EVENT. 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 INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PNN MAR +4 NEUT 32IDX50OD 87LPH LPH DEPUY ORTHOPAEDICS, INC. NA C2BDF1000

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention