BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX HOLE ELIM POSITIVE STOP

    MDR report key: 3010219 · Received March 19, 2013

    Report

    Report Number
    1818910-2013-14032
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    December 20, 2012
    Report Date
    February 18, 2013
    Manufacturer
    JOHNSON & JOHNSON MEDICAL (DEPUY - SUZHOU) LTD.
    Product Code
    LPH
    PMA / PMN Number
    PK963309
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A 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 ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    CLINICAL REPORT STATES THE PATIENT EXPERIENCED AN INITIAL DISLOCATION. TO RESOLVE THE PROBLEM THE PATIENT UNDERWENT A CLOSED REDUCTION. 02/04/2013 - THE HOLE ELIMINATOR WENT THROUGH TO JUST BENEATH THE SURFACE, SO WAS LEFT IN SITU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114133 APEX HOLE ELIM POSITIVE STOP HOLE ELIMINATOR LPH JOHNSON & JOHNSON MEDICAL (DEPUY - SUZHOU) LTD. D12071815

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention