BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL HA W/O COLLAR S12 150MM

    MDR report key: 2112957 · Received May 18, 2011

    Report

    Report Number
    1818910-2011-08496
    Event Type
    Injury
    Date Received
    May 18, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 18, 2011
    Manufacturer
    DEPUY FRANCE S.A.
    Product Code
    LZO
    PMA / PMN Number
    K953111
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 REPORTED INCIDENTS AGAINST THE KNOWN PRODUCT/LOT COMBINATIONS SINCE THEIR RELEASE FOR DISTRIBUTION. LOT INFORMATION WAS NOT PROVIDED FOR THE ASSOCIATED FEMORAL STEM. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING 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 OR 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

    PATIENT WAS REVISED TO ADDRESS FEMORAL LOOSENING, LEG LENGTH DISCREPANCY, AND INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORAIL HA W/O COLLAR S12 150MM 87LZO; 87MEH LZO DEPUY FRANCE S.A. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention