BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPUY

    MDR report key: 3231340 · Received July 11, 2013

    Report

    Report Number
    MW5030906
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    June 27, 2013
    Report Date
    July 11, 2013
    Manufacturer
    DEPUY
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT RIGHT TOTAL KNEE ARTHROSCOPY. WHILE PLACING THE IMPLANT DURING THE PROCEDURE, THE IMPACTOR HANDLE BROKE INTO 3 PIECES (2 LARGE & 1 SMALL). THE OPERATIVE SITE WAS MANUALLY SEARCHED AND FLUSHED. AN X-RAY SHOWED THE PLASTIC COMPONENTS OF THE PROSTHETIC JOINT, BUT DID NOT SHOW ANY OTHER FOREIGN BODIES. IT APPEARS THAT THE PT DID NOT SUSTAIN ANY INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321260 DEPUY HAND-HELD IMPACTOR HANDLE LXH DEPUY J1210

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR