BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA PS CEM FEM SZ3 R

    MDR report key: 3180090 · Received June 20, 2013

    Report

    Report Number
    1818910-2013-19402
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 12, 2013
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK073529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE FOR THE SIGMA PS CEM FEM AS THE LOT CODE REQUIRED WAS NOT PROVIDED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE FOR THE TIBIAL TRAY AND TIBIAL INSERT AS THE PRODUCT AND LOT CODES REQUIRED WERE NOT PROVIDED. THE INITIAL REPORTING STATED THAT NO ADDITIONAL INVESTIGATIONAL INPUTS ARE AVAILABLE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT 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

    PATIENT WAS REVISED TO ADDRESS PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279906 SIGMA PS CEM FEM SZ3 R FEMORAL KNEE PROSTHESIS JWH 1818910 DEPUY ORTHOPAEDICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention