BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMA FEM STEM BOLT

    MDR report key: 2012581 · Received February 24, 2011

    Report

    Report Number
    1818910-2011-02991
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 27, 2011
    Report Date
    January 27, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K952830
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. NO REVISION HAS BEEN REPORTED. EXAMINATION OF PROVIDED PHOTOGRAPHS CONFIRMS A FRACTURED DEVICE. THE PRODUCT CODE AND LOT CODE REQUIRED IN RETRIEVING THE DEVICE HISTORY RECORDS FOR REVIEWING AND SEARCHING THE COMPLAINT DATABASE WERE NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE DEVICE FRACTURE BASED ON THE PROVIDED INFORMATION. BASED ON THE PERFORMED INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    XRAYS SHOWS PT HAS A FRACTURED STEM/BOLT. NO REVISION HAS BEEN SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIGMA FEM STEM BOLT TOTAL KNEE JWH DEPUY ORTHOPAEDICS, INC. NA 302440

    Patients

    Seq Age Sex Outcome Treatment
    1 NA