BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIG CRUC SUB SZ3 W/LUGS LT

    MDR report key: 2771703 · Received October 4, 2012

    Report

    Report Number
    1818910-2012-20251
    Event Type
    Injury
    Date Received
    October 4, 2012
    Report Date
    September 18, 2012
    Manufacturer
    DEPUY RAYNHAM
    Product Code
    JWH
    PMA / PMN Number
    K943462
    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

    THE DEVICES ASSOCIATED WITH THIS REPORT REMAIN IMPLANTED. NO REVISION SURGERY HAS BEEN REPORTED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION. RADIOGRAPHIC INFORMATION WAS NOT AVAILABLE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT BASED ON THE PROVIDED INFORMATION. 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.

    Description of Event or Problem · 1

    CLINICAL REPORT STATES: PAINFUL SCAR TISSUE WITH RESULTANT CREPITUS FOLLOWING TKA. (LEFT KNEE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIG CRUC SUB SZ3 W/LUGS LT FEMORAL IMPLANT JWH DEPUY RAYNHAM AX9BV4000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention