BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEG SMOOTH 2.0X22MM (3 EACH)

    MDR report key: 2113215 · Received May 20, 2011

    Report

    Report Number
    1818910-2011-09063
    Event Type
    Injury
    Date Received
    May 20, 2011
    Date of Event
    April 22, 2011
    Report Date
    April 22, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXT
    PMA / PMN Number
    K050932
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE INSPECTION RECORDS FOR THE PLATE FOUND NO MFG DEVIATIONS OR REJECTIONS. REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE LOT CODES REQUIRED FOR THE PEGS WERE NOT PROVIDED. PROVIDED INFO STATES THE SURGEON THINKS THE POSSIBLE CAUSES ARE INFECTION OR METAL REACTIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFO PROVIDED. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADD'L INFO BE REC'D TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT REVISED FOR PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEG SMOOTH 2.0X22MM (3 EACH) 87 LXT LXT DEPUY ORTHOPAEDICS, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention