BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN STEMMED TIBIAL BROACH IMPACTOR

    MDR report key: 1926411 · Received November 11, 2010

    Report

    Report Number
    1822565-2010-01119
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    September 13, 2010
    Report Date
    October 15, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    HWA
    Removal / Correction Number
    1822565-03/18/2010-004R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICES ARE BEING RETURNED DUE TO THE THUMB PIN LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN STEMMED TIBIAL BROACH IMPACTOR KNEE INSTRUMENT HWA ZIMMER, INC. 60226046

    Patients

    Seq Age Sex Outcome Treatment
    1 LOT #72502300| NEXGEN COMPLETE KNEE SOLUTION STEMMED TIBIAL| BROACH IMPACTOR, CATALOG #00597701100,