BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN FEMORAL IMPACTOR/EXTRACTOR JAW

    MDR report key: 2063166 · Received March 22, 2011

    Report

    Report Number
    1822565-2011-00713
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Report Date
    February 22, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    MBH
    Removal / Correction Number
    1822565-2/24/2011-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: SUBCOMPONENT GEOMETRY HAS BEEN IMPROVED TO STRENGTHEN THE DEVICE. FURTHERMORE, ALL DEVICES MANUFACTURED PRIOR TO THE IMPLEMENTATION OF THIS CHANGE ARE BEING REMOVED FROM THE FIELD AS PART OF A REPORTABLE FIELD ACTION. REFERENCE REMOVAL REPORT 1822565-2/24/2011-001-R FOR ADDITIONAL DETAILS. AS RETURNED, THE SPRING CLIP IS FRACTURED ON BOTH ITEMS. BOTH ITEMS ALSO EXHIBIT IMPACT MARKS AND GOUGES. DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPECIFICATION AT THE TIME OF MANUFACTURE. DIMENSIONAL READINGS AND MATERIAL HARDNESS ARE CONFORMING TO PRINT SPECIFICATIONS.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE SPRING CLIP HAS FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN FEMORAL IMPACTOR/EXTRACTOR JAW MBH ZIMMER, INC. 61542077

    Patients

    Seq Age Sex Outcome Treatment
    1 CATALOG #00590102600, LOT# 61542077| NEXGEN FEMORAL IMPACTOR/EXTRACTOR JAW