BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIG FEM POST AUG SZ2.5 8MM

    MDR report key: 1233605 · Received November 14, 2008

    Report

    Report Number
    1818910-2008-04993
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    September 30, 2008
    Report Date
    October 15, 2008
    Manufacturer
    DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC
    Product Code
    JWH
    PMA / PMN Number
    K952830
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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

    PT WAS REVISED TO ADDRESS LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIG FEM POST AUG SZ2.5 8MM 87JWH JWH DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC NA 304538

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention