BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL HEAD IMPLANT

    MDR report key: 14273 · Received March 22, 1994

    Report

    Report Number
    33458-1994-00002
    Event Type
    Injury
    Date Received
    March 22, 1994
    Date of Event
    February 24, 1994
    Report Date
    March 22, 1994
    Manufacturer
    ZIMMER PRODUCT SERVICE DISTRIBUTION CENTER
    Product Code
    JDD
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON 1/11/94 A FEMORAL HEAD WAS IMPLANTED ON A CEENTRALIGN STEM. EVERYTHING APPEAREED TO BE ALRIGHT.. ON 2/24/94 THE PT COMPLAINED OF PAAIN, AN X-RAY WAS TAKEN AAND THE FEMORAL HEAD SHOWEEED TO HAVE COME LOOSE FROM THE FEMORAL STEM. ON 2/28/94 REVISION SURGERY WAS PERFORMED AND THE FEMORAL HEAD WAS REMOVED FROM THE PT, THE MORSE TAPER ON THE STEM WAS EXAMINEED BY THE SURGEON AND APPEARED TO BE ALRIGHT. A NEW FEMORAL HEAD WAS PLACED ON THE STEMMM AND TIGHTNESSS WAS TESTED BY THE SURGEON AND WAS SATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEMORAL HEAD IMPLANT Implant FEMORAL HEAD JDD ZIMMER PRODUCT SERVICE DISTRIBUTION CENTER NA 50020600

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention