BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICUL/EZE CER BALL 32 +5

    MDR report key: 2920469 · Received January 17, 2013

    Report

    Report Number
    1818910-2013-11125
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 9, 2013
    Manufacturer
    DEPUY IRELAND ¿ REG. # 9616671
    Product Code
    MRA
    PMA / PMN Number
    PP040023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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

    PATIENT WAS REVISED TO ADDRESS RECURRENT DISLOCATION. MILKY FLUID WAS ALSO NOTED. DOI (B)(6) 2011 - DOR (B)(6) 2013 (LEFT HIP). 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. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH (B)(4) APPENDIX A; REV. C. NO ADDITIONAL INFORMATION WAS OBTAINED. 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 INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS RECURRENT DISLOCATION. MILKY FLUID WAS ALSO NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25515 ARTICUL/EZE CER BALL 32 +5 FEMORAL HEAD MRA DEPUY IRELAND ¿ REG. # 9616671 3117722

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention