BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER

    MDR report key: 301545 · Received October 20, 2000

    Report

    Report Number
    301545
    Event Type
    Injury
    Date Received
    October 20, 2000
    Date of Event
    October 9, 2000
    Report Date
    October 9, 2000
    Manufacturer
    COMEG ENDOSKOPIE GMBH
    Product Code
    HRX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT PRESENTED TO THE AMBULATORY SURGICAL UNIT TO UNDERGO A LEFT KNEE ARTHROSCOPY WITH DEBRIDEMENT OF MEDIAL FEMORAL CONDYLE AND TROCHLEAR GROOVE. AT THE BEGINNING OF THE SURGERY WHEN THE ARTHROSCOPE WAS INSERTED, THE INITIAL VIEW THROUGH THE ARTHROSCOPE WAS UNCLEAR. AS THE ARTHROSCOPE WAS REMOVED FROM THE KNEE, IT WAS NOTED THAT THERE WAS A DISASSEMBLY OF THE COMPONENTS OF THE ARTHROSCOPE TIP. AFTER A NEW ARTHROSCOPE WAS INSERTED AND A CLEAR VISUALIZATION WAS OBTAINED, A SMALL METAL CYLINDRICAL RING WAS SEEN IN THE INTERCONDYLAR NOTCH. THIS OBJECT WAS IMMEDIATELY REMOVED WITH A GRASPER. ALSO NOTED, WAS A SMALL CLEAR COMPONENT WAS LYING LATERAL TO THE INTERIOR CRUCIATE LIGAMENT. IT WAS UNABLE TO BE GRASPED AND REMOVED DURING THE PROCEDURE. POST OPERATIVELY X-RAYS REVEALED A SMALL OPAQUE DENSITY APPEARING IN THE POSTLATERAL PORTION OF THE KNEE. AN ARTHOSCOPY IS SCHEDULED TO REMOVE THE FOREIGN BODY. DEVICE RECEIVED BY THIS FACILITY ON 05/18/1993 FROM ZIMMER, INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER 30 DEGREE ARTHROSCOPE HRX COMEG ENDOSKOPIE GMBH * *

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R