BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS PW IM HOLE LOCATOR

    MDR report key: 2113079 · Received May 18, 2011

    Report

    Report Number
    1818910-2011-08885
    Event Type
    Injury
    Date Received
    May 18, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 18, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED PRODUCT CONFIRMED THE REPORTED EVENT. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT. BASED ON THE INVESTIGATION FINDINGS, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    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.

    Description of Event or Problem · 1

    FEMORAL FRACTURE OCCURRED VERTICALLY FROM INTERCONDYLAR WHEN THE DEVICE WAS HAMMERED IN THE INTERCONDYLAR. BONE HOLDING FORCEPS WERE USED TO KEEP THE FEMORAL BONE THROUGHOUT THE SURGERY, THE SURGERY PROLONGED 20 MINS. BONE CEMENT WAS USED FOR THE SURGERY THOUGH IT WAS PLANNED TO USE CEMENTLESS IMPLANTS INITIALLY. THE PT CONDITION WAS GOOD AFTER THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCS PW IM HOLE LOCATOR 87LXH LXH DEPUY ORTHOPAEDICS, INC. NA A0906

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention