BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA PS CEM FEM SZ4N L

    MDR report key: 3042886 · Received April 9, 2013

    Report

    Report Number
    1818910-2013-06486
    Event Type
    Injury
    Date Received
    April 9, 2013
    Report Date
    March 12, 2013
    Manufacturer
    DEPUY RAYNHAM
    Product Code
    JWH
    PMA / PMN Number
    K073529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED. 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 WITH THIS NEWLY PROVIDED INFORMATION. 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 PATELLAR GRIND SYNDROME. UPDATE: (B)(4) 2013 - ADDITIONAL INFORMATION WAS RECEIVED FROM CLINICAL. THE PATIENT UNDERWENT AN ARTHROSCOPY TO ADDRESS THEIR PATELLAR GRIND SYNDROME. THE MDR DECISION ON THE COMPLAINT WAS CHANGED. DATE OF ARTHROSCOPY WAS (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146145 SIGMA PS CEM FEM SZ4N L FEMORAL JWH DEPUY RAYNHAM 131823

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention