BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERED SPACER ARTICUL/EZE -3

    MDR report key: 2071529 · Received April 15, 2011

    Report

    Report Number
    1818910-2011-06424
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 18, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LZY
    PMA / PMN Number
    K903084
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    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. REVIEW OF THE STERILIZATION CERTIFICATIONS DID NOT REVEAL ANY RELATED DEVIATIONS OR ANOMALIES. 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 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

    PT WAS REVISED TO ADDRESS INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAPERED SPACER ARTICUL/EZE -3 87LZY LZY DEPUY ORTHOPAEDICS, INC. NA E6CLD1000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention