BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAVE ACTIVE PFC CVD 8MM SZ2

    MDR report key: 2831380 · Received November 14, 2012

    Report

    Report Number
    1818910-2012-27716
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 5, 2012
    Product Code
    JWH
    PMA / PMN Number
    K830927
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE LOT CODE REQUIRED WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED POLY WEAR WITHOUT THE PRODUCT TO EXAMINE. 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

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAVE ACTIVE PFC CVD 8MM SZ2 TIBIAL KNEE INSERT JWH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention