BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BANTAM FEM HEAD 28MM+0

    MDR report key: 2142735 · Received June 23, 2011

    Report

    Report Number
    1818910-2011-02048
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 4, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    LPH
    PMA / PMN Number
    K013012
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A WORLDWIDE COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS SINCE THEIR RELEASE FOR DISTRIBUTION. 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 INFO BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT REVISED DUE TO CHRONIC DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BANTAM FEM HEAD 28MM+0 87LPH LPH DEPUY INTERNATIONAL, LTD. NA 2245223

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention