BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIG FEM POST AUG SZ2.5 4MM

    MDR report key: 2923750 · Received January 22, 2013

    Report

    Report Number
    1818910-2013-11195
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 10, 2013
    Manufacturer
    DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK952830
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION. IT WAS STATED IN THE INITIAL REPORTING THAT NO ADDITIONAL EVENT INFORMATION IS AVAILABLE. 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

    PATIENT WAS REVISED TO ADDRESS INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29840 PFC SIG FEM POST AUG SZ2.5 4MM KNEE AUGMENT JWH DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS E24K14

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention