BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAVE ACTIVE PFC PLI 10MM SZ2

    MDR report key: 2922388 · Received January 18, 2013

    Report

    Report Number
    1818910-2013-11171
    Event Type
    Injury
    Date Received
    January 18, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 10, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK830927
    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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. PATIENT X-RAYS WERE NOT AVAILABLE FOR EXAMINATION. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE LOT CODES REQUIRED WERE NOT PROVIDED. THE INVESTIGATION COULD NOT CONFIRM OR DRAW ANY CONCLUSIONS ABOUT THE REPORTED POLYETHYLENE WEAR OR OSTEOLYSIS BASED ON THE PROVIDED INFORMATION. BASED ON THE INABILITY TO IDENTIFY PRODUCT ERROR AS A CONTRIBUTING FACTOR OR 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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS POLY WEAR OF THE TIBIAL INSERT AND OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27443 LEAVE ACTIVE PFC PLI 10MM SZ2 TIBIAL KNEE INSERT JWH DEPUY ORTHOPAEDICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention