BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL AND PROVISIONAL IMPACTOR/EXTRACTOR

    MDR report key: 2100572 · Received May 17, 2011

    Report

    Report Number
    1822565-2011-01202
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    February 24, 2011
    Report Date
    April 18, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    MBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A HEALTH PROFESSIONAL WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: TWO PRI FEMORAL INSERTER/EXTRACTOR DEVICES WERE RETURNED FOR EVAL. THE REPLACEMENT JAW ASSEMBLY ATTACHED TO LOT NUMBER: 61637191 APPEARS TO HAVE FRACTURED AT THE NARROWEST PART OF THE CLIP NEAR THE HOLE THAT MATES WITH THE END OF THE SPRING PIN SUBCOMPONENT. IT ALSO APPEARS, HOWEVER, THAT THE ASSEMBLY WAS ATTACHED INCORRECTLY. THE ASSEMBLY IS ORIENTED UPSIDE DOWN FROM THE INTENDED DESIGN. THEREFORE, IT IS POSSIBLE THAT THE ASSEMBLY EXPERIENCED LOADS THAT WERE NOT INTENDED DURING THE DESIGN OF THE DEVICE. THE REPLACEMENT JAW ASSEMBLY THAT WAS RETURNED FULLY DISASSEMBLED APPEARS TO HAVE FRACTURED IN TWO PLACES NEAR THE CLIP/PIN/PEG JUNCTION. OVERALL, SEM ANALYSIS SUGGESTS THAT IT IS POSSIBLE THE FRACTURE MAY HAVE OCCURRED DUE TO REPEATED LOADING. IF THIS REPLACEMENT JAW ASSEMBLY WAS INCORRECTLY ATTACHED SIMILAR TO THE PREVIOUS ASSEMBLY, IT IS POSSIBLE THAT THE REPEATED LOADING OCCURRED IN LOCATIONS THAT WERE NOT INTENDED TO RECEIVE SUCH LOADS. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECS.

    Description of Event or Problem · 1

    IT IS REPORTED THAT A PIECE OF THE FEMORAL IMPACTOR BROKE DURING USE. THE SURGEON BEGAN CLOSURE OF THE FIRST WOUND LAYER WHILE AWAITING AN X-RAY TO FIND MISSING PIECE. THE PT WAS REOPENED TO RETRIEVE THE BROKEN PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEMORAL AND PROVISIONAL IMPACTOR/EXTRACTOR MBH ZIMMER, INC. 61610343

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CATALOG # 00590102600, LOT # 61637191| FEMORAL AND PROVISIONAL IMPACTOR/EXTRACTOR: