BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY AMK TIBIAL INSERT

    MDR report key: 2020096 · Received March 11, 2011

    Report

    Report Number
    1818910-2011-03935
    Event Type
    Injury
    Date Received
    March 11, 2011
    Date of Event
    February 9, 2011
    Report Date
    February 9, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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

    PATIENT FELL A FEW MONTHS AGO AND HER TIBIAL TRAY COLLAPSED AND LOOSENED ON MEDIAL SIDE. SHE HAD METALLOSIS EVERYWHERE, AS WELL AS SLIGHT POLY WEAR OF THE INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY AMK TIBIAL INSERT TOTAL KNEE PROSTHESIS JWH DEPUY ORTHOPAEDICS, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention