BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC*SIGMA/RD/DOME PAT 3PEG,35

    MDR report key: 3242171 · Received July 23, 2013

    Report

    Report Number
    1818910-2013-21875
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    April 1, 2010
    Report Date
    June 28, 2013
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK884796
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT REMAINS IMPLANTED. NO REVISION SURGERY HAS BEEN REPORTED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT LOT CODE REQUIRED WAS NOT PROVIDED. THE INITIAL REPORTING STATED NO ADDITIONAL EVENT INFORMATION WAS AVAILABLE. 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 ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    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 THE PATIENT HAD A FULL REVISION FOR LOOSE CEMENTED FEMUR AND TIBIA / FAILED PATELLA 59 MOS AFTER PARTIAL REVISION AT ACI (TIBIA & INSERT ONLY-18 MOS. AFTER PRIMARY TKA)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344207 PFC*SIGMA/RD/DOME PAT 3PEG,35 PATELLA JWH 1818910 DEPUY ORTHOPAEDICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention