BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIS QUAD-SPARING INSERTER/EXTRACTOR PAD

    MDR report key: 1931675 · Received November 22, 2010

    Report

    Report Number
    1822565-2010-01166
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 25, 2010
    Report Date
    October 25, 2010
    Manufacturer
    ZIMMER INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: AS RETURNED, A PORTION OF THE DEVICE IS FRACTURED. THE DEVICE HAS A POTENTIAL FIELD AGE OF APPROXIMATELY 12 MONTHS, BASED UPON THE LOT NUMBER. IN GENERAL, IMPACTORS BECOME DAMAGED THROUGH REPEATED USE DUE TO IMPACTIONS SUSTAINED WHILE IN USE. IMPACTORS OR IMPACTOR HEADS SHOULD BE REPLACED WHEN THE PART IS NO LONGER FUNCTIONING. EVAL: DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPECIFICATION. SCANNING ELECTRON MICROSCOPY (SEM) ANALYSIS/ENERGY DISPERSIVE SPECTROSCOPY (EDS) ANALYSIS WAS PERFORMED. NO MANUFACTURING ABNORMALITIES COULD BE DETECTED BY EITHER METHOD.

    Description of Event or Problem · 1

    IT IS REPORTED THAT UPON IMPACTION OF TRIAL FEMORAL COMPONENT INTO PT THE IMPACTOR PAD FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIS QUAD-SPARING INSERTER/EXTRACTOR PAD KNEE INSTRUMENT LXH ZIMMER INC. 61377486

    Patients

    Seq Age Sex Outcome Treatment
    1