BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC*SIGMA C/S NPOR FEM LT SZ 4

    MDR report key: 3943436 · Received July 18, 2014

    Report

    Report Number
    1818910-2014-23734
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    July 13, 2009
    Report Date
    June 24, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED AND IS PRESUMED YET IMPLANTED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE FOR THE LOT CODE REQUIRED WAS NOT PROVIDED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    CLINICAL REPORT STATES THAT PATIENT UNDERWENT ARTHROSCOPY WITH PARTIAL SYNOVECTOMY FOR PATELLAR CREPITUS 33 MONTHS AFTER PRIMARY TKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422619 PFC*SIGMA C/S NPOR FEM LT SZ 4 KNEE FEMORAL COMPONENT JWH DEPUY ORTHOPAEDICS, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention