BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC*SIGMA TC3 FEM RT SZ3

    MDR report key: 3242871 · Received July 23, 2013

    Report

    Report Number
    1818910-2013-21908
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    January 11, 2011
    Report Date
    June 28, 2013
    Manufacturer
    3006356043 JOHNSON & JOHNSON MEDICAL (DEPUY - SUZH
    Product Code
    JWH
    PMA / PMN Number
    PK952830
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT REMAINS IMPLANTED. NO REVISION SURGERY HAS BEEN REPORTED. THE INITIAL REPORTING STATED RADIOGRAPHIC REVIEWS ARE NOT AVAILABLE. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. 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 DEVICE AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    CLINICAL REPORT STATES THE PATIENT HAD PERIPATELLAR CREPITUS THAT WAS TREATED WITH AN ARTHROSCOPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343093 PFC*SIGMA TC3 FEM RT SZ3 FEMORAL JWH 3006356043 JOHNSON & JOHNSON MEDICAL (DEPUY - SUZH DB3E91000

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention