BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING IMPACTOR/EXTRACTOR

    MDR report key: 1871085 · Received October 12, 2010

    Report

    Report Number
    1822565-2010-00876
    Event Type
    Injury
    Date Received
    October 12, 2010
    Date of Event
    June 16, 2010
    Report Date
    September 13, 2010
    Manufacturer
    ZIMMER INC
    Product Code
    HWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE SURGEON WAS USING THIS INSTRUMENT, THREE PARTS OF IT DROPPED OUT. THE SURGEON REMOVED TWO PARTS DURING THE PROCEDURE. THE NEXT DAY, THE SURGEON NOTICED THAT ONE PART REMAINED IN THE PT'S BODY. ADDITIONAL SURGERY WAS REQUIRED TO RECOVER THE REMAINING PORTION OF THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCKING IMPACTOR/EXTRACTOR KNEE INSTRUMENT HWA ZIMMER INC 60530492

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention