BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIS QUAD-SPARING FEMORAL INSERTER/EXTRACTOR

    MDR report key: 2110020 · Received May 17, 2011

    Report

    Report Number
    1822565-2011-01197
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Report Date
    April 21, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    HWA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: 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 MFG AND INSPECTED TO SPEC. THE FRACTURED PAD WAS NOT RETURNED FOR EVAL. BASED ON THE LOT NUMBER, THE IMPACTOR HAS A POTENTIAL FIELD AGE OF APPROX 4.5 YEARS AND HAS BEEN USED AN UNK NUMBER OF TIMES DURING THAT PERIOD.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE IMPACTOR PAD HAS FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIS QUAD-SPARING FEMORAL INSERTER/EXTRACTOR HWA ZIMMER, INC. 60572535

    Patients

    Seq Age Sex Outcome Treatment
    1