BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING FEMORAL IMPACTOR/EXTRACTOR

    MDR report key: 1963602 · Received December 21, 2010

    Report

    Report Number
    1822565-2010-01392
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    October 19, 2010
    Report Date
    November 16, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    HWA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT PIECES OF THE INSTRUMENTS BROKE OFF.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 LOCKING FEMORAL IMPACTOR/EXTRACTOR,| CATALOG # 00590102640, LOT# UNK