BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFCSIG POSTLIP INSERT SZ5 8MM

    MDR report key: 1812472 · Received August 16, 2010

    Report

    Report Number
    1818910-2010-05407
    Event Type
    Injury
    Date Received
    August 16, 2010
    Date of Event
    July 20, 2010
    Report Date
    July 20, 2010
    Manufacturer
    DEPUY- RAYNHAM, A DIV OF DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K943462
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    THE PT WAS REVISED DUE TO POLY WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFCSIG POSTLIP INSERT SZ5 8MM 87JWH JWH DEPUY- RAYNHAM, A DIV OF DEPUY ORTHOPAEDICS, INC. NA 02577A

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention