BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +5

    MDR report key: 2122699 · Received June 3, 2011

    Report

    Report Number
    1818910-2011-09815
    Event Type
    Injury
    Date Received
    June 3, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 4, 2011
    Manufacturer
    DEPUY INTL. LTD.
    Product Code
    JDI
    PMA / PMN Number
    K980513
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT WITH THE PROVIDED INFORMATION. NO EVIDENCE WAS FOUND SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD 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 REVISED FOR INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTICULEZE M HEAD 36MM +5 87 JDI, LPH JDI DEPUY INTL. LTD. NA 3261689

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention