BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINN LNR CON +4 NEUT 32IDX54OD

    MDR report key: 1083921 · Received July 28, 2008

    Report

    Report Number
    1818910-2008-02992
    Event Type
    Malfunction
    Date Received
    July 28, 2008
    Date of Event
    July 3, 2008
    Report Date
    July 3, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWZ
    PMA / PMN Number
    K043058
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE DEVICE WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT CODE SINCE ITS RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT ERROR WITH REGARD TO THE REPORTED EVENT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    LINER FRACTURED DURING REDUCTION EXTENDING THE SURGICAL PROCEDURE BY MORE THAN 15 MINUTES. ALL PIECES RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINN LNR CON +4 NEUT 32IDX54OD 87KWZ KWZ DEPUY ORTHOPAEDICS, INC. NA CF4AY1000

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR