BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC*SIGMA C/S NPOR FE LT SZ2.5

    MDR report key: 2935684 · Received January 30, 2013

    Report

    Report Number
    1818910-2013-11665
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    September 15, 2005
    Report Date
    January 10, 2013
    Manufacturer
    DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK950010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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. THE INITIAL REPORTING STATES RADIOGRAPHIC REVIEWS ARE NOT AVAILABLE. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCTS AND LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION. 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 THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    CLINICAL REPORT STATES PATELLA CLUNK SYNDROME. PATIENT UNDERWENT AN ARTHROSCOPIC DEBRIDEMENT ON (B)(6) 2005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40339 PFC*SIGMA C/S NPOR FE LT SZ2.5 FEMORAL HEAD JWH DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS 279852

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention