BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC C/R FEM CEM LFT SZ4

    MDR report key: 2060684 · Received April 6, 2011

    Report

    Report Number
    1818910-2011-05878
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 9, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K884796
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. PRODUCT INFORMATION REQUIRED IN SEARCHING THE COMPLAINT DATABASE BY PRODUCT LOT CODE WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT BASED ON THE LACK OF THE PRODUCT TO EXAMINE AND INSUFFICIENT PRODUCT INFORMATION. IT WAS NOTED THE PRODUCT WAS IMPLANTED, APPROXIMATELY TWENTY YEARS PRIOR TO REVISION. BASED ON THE PERFORMED INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS 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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS KNEE PAIN DUE TO LOOSENING OF THE FEMUR AND TIBIA. POLY WEAR AND OSTEOLYSIS WERE ALSO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC C/R FEM CEM LFT SZ4 87JWH JWH DEPUY ORTHOPAEDICS, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention