BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 STD SIZE 14

    MDR report key: 3131867 · Received May 29, 2013

    Report

    Report Number
    1818910-2013-17752
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    April 30, 2013
    Report Date
    April 30, 2013
    Manufacturer
    DEPUY FRANCE S.A.S.-SAINT PRIEST ¿ REG. # 30038955
    Product Code
    KWA
    PMA / PMN Number
    PK042992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING. 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 CUP OR STEM'S PROVIDED PRODUCT AND LOT COMBINATIONS SINCE THEIR RELEASE FOR DISTRIBUTION. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE LINER AND HEAD REVEALED NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. 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. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    PATIENT SEEKING LEGAL ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235822 CORAIL2 STD SIZE 14 FEMORAL STEM KWA DEPUY FRANCE S.A.S.-SAINT PRIEST ¿ REG. # 30038955 2490096

    Patients

    Seq Age Sex Outcome Treatment
    1 Other