BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAVE ACTIVE PFC CVD 10MM SZ5

    MDR report key: 2539605 · Received April 18, 2012

    Report

    Report Number
    1818910-2012-10104
    Event Type
    Injury
    Date Received
    April 18, 2012
    Date of Event
    March 23, 2012
    Report Date
    March 23, 2012
    Manufacturer
    K830927
    Product Code
    JWH
    PMA / PMN Number
    K830927
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. PRODUCT INFORMATION REQUIRED IN RETRIEVING THE DEVICE HISTORY RECORDS FOR REVIEWING AND SEARCHING THE COMPLAINT DATABASE WERE 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 FOR APPROXIMATELY EIGHTEEN YEARS PRIOR TO REVISION. BASED ON THE PERFORMED INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. IN ADDITION, THE PRODUCT CODE IS AN OBSOLETE ITEM. 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 INSTABILITY. POLY WEAR OF THE INSERT PATELLA WERE ALSO REPORTED. (RIGHT KNEE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAVE ACTIVE PFC CVD 10MM SZ5 KNEE IMPLANT JWH K830927 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention