BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAVE ACTIVE PFC PLI 10MM SZ5

    MDR report key: 1153053 · Received September 5, 2008

    Report

    Report Number
    1818910-2008-03879
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    July 30, 2008
    Report Date
    August 6, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K884796
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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

    FURTHER INFORMATION RECEIVED 14 AUGUST - COMPONENT FAILURE. THE INSERT WAS WORN MEDIALLY, AND THERE WAS A FRACTURE OF THE TIBIAL TRAY ORIGINATING POSTERIORLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAVE ACTIVE PFC PLI 10MM SZ5 87 JWH JWH DEPUY ORTHOPAEDICS, INC. NA 01249A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention