BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIG MOD TIB TRAY CEM COCR 2.5

    MDR report key: 2151284 · Received June 30, 2011

    Report

    Report Number
    1818910-2011-11550
    Event Type
    Injury
    Date Received
    June 30, 2011
    Date of Event
    May 31, 2011
    Report Date
    May 31, 2011
    Manufacturer
    DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS
    Product Code
    JWH
    PMA / PMN Number
    K032151
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 REVISED FOR LOOSE TIBIAL TRAYS UNKNOWN INTERFACE WITH DEPUY CEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIG MOD TIB TRAY CEM COCR 2.5 87 JWH JWH DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS NA BY3MA4000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention