BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICUL/EZE CER BALL 28 +1.5

    MDR report key: 3072688 · Received April 23, 2013

    Report

    Report Number
    1818910-2013-15748
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 10, 2013
    Manufacturer
    DEPUY (IRELAND) 9616671
    Product Code
    LZO
    PMA / PMN Number
    PK931024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A; REV. D. NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED FRACTURE AFTER NEARLY SIX YEARS IMPLANTED WITHOUT DEVICE EVALUATION. 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 A FRACTURED CERAMIC HEAD. IT WAS REPORTED THAT THE PATIENT SAT DOWN AND HEARD A "POP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173945 ARTICUL/EZE CER BALL 28 +1.5 FEMORAL HEAD LZO DEPUY (IRELAND) 9616671 1862259

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention