BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN FEMORAL IMPACTOR/EXTRACTOR JAW

    MDR report key: 2063192 · Received March 22, 2011

    Report

    Report Number
    1822565-2011-00705
    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

    INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. 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 (B)(4) FOR ADDITIONAL DETAILS. EVALUATION: SUBCOMPONENT SPRING CLIP FRACTURE IS REPORTED AND OBSERVED. REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. 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.

    Patients

    Seq Age Sex Outcome Treatment
    1