BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC*SIGMA C/S NPOR FEM LT SZ 3

    MDR report key: 3200912 · Received July 2, 2013

    Report

    Report Number
    1818910-2013-20328
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    June 12, 2013
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK950010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. PRODUCT INFORMATION REQUIRED IN RETRIEVING THE DEVICE HISTORY RECORDS FOR REVIEW AND/OR SEARCHING THE COMPLAINT DATABASE BY LOT CODE WAS NOT PROVIDED. THE INITIAL REPORTING STATED NO ADDITIONAL INVESTIGATIONAL INPUTS WERE AVAILABLE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT BASED ON THE INFORMATION PROVIDED. 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 AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    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.

    Description of Event or Problem · 1

    CLINICAL REPORT STATES THE PATIENT HAD AN ARTHROSCOPY WITH LIMITED SYNOVECTOMY FOR PATELLAR CLUNK 28 MOS AFTER PRIMARY TKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303259 PFC*SIGMA C/S NPOR FEM LT SZ 3 FEMORAL JWH 1818910 DEPUY ORTHOPAEDICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention