BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COONRAD/MORREY PIN/BUSHING REPLACEMENT KIT

    MDR report key: 3890675 · Received June 2, 2014

    Report

    Report Number
    1822565-2014-00682
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE ACTIVITY LEVEL OF THE PT WAS NOTED AS "MEDIUM". THE ZIMMER "COONRAD/MORREY TOTAL ELBOW" INSTRUCTIONS FOR USE INCLUDED WITH THE IMPLANT ,STATES THAT THE PT MUST NOT LIFT MORE THAN FIVE POUNDS WITH THE OPERATED ARM. IT IS UNK IF THE PT'S ACTIVITIES WOULD HAVE STRESSED THE JOINT BEYOND THE FIVE POUND LIMIT. CAUSE CANNOT BE DEFINITIVELY DETERMINED. NO LOT NUMBER WAS PROVIDED; THEREFORE, DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. RETURNED FOR ANALYSIS IS THE REPLACEMENT KIT CONSISTING OF THE INNER AND OUTER PINS, AS WELL AS THE ULNAR AND HUMERAL BUSHINGS. AS RETURNED THE INNER PIN IS FRACTURED AT THE TINES. THE FRACTURE IS CONSISTENT WITH OTHERS THAT HAVE RESULTED IN OVERLOADING. TWO OF THE FOUR TINES WERE RETURNED, THE LOCATIONS OF THE OTHER TWO TINES IS UNK. THE BUSHINGS WERE WORN AS WELL AS THE SHAFT OF THE OUTER PINS. THIS WEAR IS MOST LIKELY A RESULT OF THE INNER PIN BREAKAGE. DAMAGE IS TOO SEVERE FOR DIMENSIONAL ANALYSIS. THE INNER PIN WAS RETURNED WITH THE FOUR TINES FRACTURED FROM THE MAIN BODY. TWO OF FOUR TINES ARE MISSING. THE MAIN BODY OF THE INNER PIN EXHIBITS WEAR & TEAR. DAMAGE IS TOO SEVERE FOR DIMENSIONAL ANALYSIS. THE OUTER PIN WAS RETURNED IN GOOD CONDITION BUT SHOWS SLIGHT WEAR/BURNISHING. DIMENSIONAL ANALYSIS IS CONFORMING TO PRINT SPECIFICATIONS.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED DUE TO PAIN AND THE PINS BECOMING DISENGAGED FROM EACH OTHER. DURING REVISION, IT WAS NOTED THAT THE PIN WAS FRACTURED AND CAME OUT IN MULTIPLE PIECES AND HAD WORN INTO THE POLY BEARINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322600 COONRAD/MORREY PIN/BUSHING REPLACEMENT KIT JDC ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention