BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY

    MDR report key: 2123014 · Received June 7, 2011

    Report

    Report Number
    2123014
    Event Type
    Injury
    Date Received
    June 7, 2011
    Date of Event
    May 3, 2011
    Report Date
    June 6, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HTG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2009. IT IS ASSERTED THAT HE EXPERIENCED UNRELIEVED PAIN SINCE SURGERY. ON (B)(6) 2011, THE PT UNDERWENT A REVISION RIGHT TOTAL KNEE REPLACEMENT. FOR ASEPTIC LOOSENING OF THE RIGHT TOTAL KNEE, THE OPERATIVE REPORT IDENTIFIED THE PATELLA TO BE LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY DOME PATELLA WITH CENTRAL PEG 38MM HTG DEPUY ORTHOPAEDICS, INC. 2866866
    2 DEPUY CROSS LINKED STABLIZED INSERT 10MM JWH DEPUY ORTHOPAEDICS, INC. 2678295

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention MODULAR TIBIAL TRAY CEMENTED COCR #2961332| SMARTSET GMV, GENTAMICIN BONE CEMENT LOT# 2906234