BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ORTHOPAEDICS, INC.

    MDR report key: 565459 · Received December 23, 2004

    Report

    Report Number
    MW1034065
    Event Type
    Injury
    Date Received
    December 23, 2004
    Date of Event
    December 20, 2004
    Report Date
    December 23, 2004
    Manufacturer
    DEPUY ORTHOPADICS, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MS, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 3/1/2005: THE MFG LOT NUMBER WAS NOT PROVIDED IN THE REPORT AND THE PRODUCT WAS NOT RETURNED FOR EVAL. THE COMPLAINT WAS ORIGINALLY REC'D THROUGH MFR'S SALES AGENT ON DEC 23, 2004. NO ADD'L INFO WAS PROVIDED. THE INITIAL MEDWATCH REPORT (REPORT NO: 1818910-2005-00052) WAS SUBMITTED VIA FAX TO THE FDA ON JANUARY 7, 2005 AND A FOLLOW-UP MEDWATCH REPORT WAS SENT ON JANUARY 27, 2005.

    Description of Event or Problem · 1

    WHILE PT WAS UNDERGOING TOTAL KNEE ARTHROPLASTY REVISION, THE FEMORAL COMPONENT OF THE TRIAL DISENGAGED AND THE STEM BECAME IMPACTED IN THE FEMORAL CANAL. AFTER ABOUT ONE HOUR AND 45 MINUTES WAS SPENT TRYING TO REMOVE THE DISENGAGED PIECE, IT WAS DETERMINED BY THE PHYSICIAN THAT IT WAS SAFEST TO ABANDON THE PROCEDURE AND TO CONTINUE AT A LATER DAY AFTER THE PT HAS RECOVERED FROM THE FOUR HOURS OF SURGERY THEY HAD JUST UNDERTAKEN AND ALL NECESSARY EQUIPMENT WAS AVAILABLE. PRESENTLY, THE PT IS RECUPERATING ON AN ACUTE CARE WARD. VITAL SIGNS ARE NORMAL. RIGHT KNEE IMMOBILIZER IS IN PLACE. THE PLAN IS TO RETURN PT TO OPERATING ROOM FOR TROCHANTERIC APPROACH TO REMOVE IMPLANT AND FINISH REVISION TKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY ORTHOPAEDICS, INC. TOTAL KNEE ARTHROPLASTY REVISION JWH DEPUY ORTHOPADICS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L