BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN IMPACTOR/EXTRACTOR REPLACEMENT JAW

    MDR report key: 2093416 · Received April 12, 2011

    Report

    Report Number
    1822565-2011-00911
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Report Date
    March 14, 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
    CA, 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: 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. (B)(4). EVAL: 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 SPECS.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE SPRING CLIP HAS BROKEN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 CATALOG #00590102640, LOT #UNK| NEXGEN IMPACTOR/EXTRACTOR REPLACEMENT JAW: