BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERSONA TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM

    MDR report key: 5762900 · Received June 30, 2016

    Report

    Report Number
    0001822565-2016-02246
    Event Type
    Malfunction
    Date Received
    June 30, 2016
    Report Date
    January 19, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK113369
    Removal / Correction Number
    Z-1052-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES THIS DEVICE IS USED FOR TREATMENT. PREVIOUS INVESTIGATION FOUND THAT SONIC CLEANING MAY BE A CONTRIBUTING FACTOR TO THE EJECTING OF THE BALL AND SPRING FROM THE PERSONA TASP SHIMS, AND THAT A USER NEED OF THE DEVICE TO BE ABLE TO WITHSTAND ULTRASONIC CLEANING WAS NOT IDENTIFIED DURING DEVELOPMENT. ZIMMER INITIATED A FIELD ACTION ON DECEMBER 11, 2014. THE INSTRUMENT WAS MANUFACTURED BEFORE THE RECALL WAS LAUNCHED AND BEFORE ANY RE-DESIGN WAS IMPLEMENTED. AS SUCH, A PREVIOUSLY ADDRESSED DESIGN ISSUE IS CONSIDERED AS THE ROOT CAUSE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE BALL BEARINGS ARE MISSING FROM THE PROVISIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415555 PERSONA TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM KNEE PROVISIONAL JWH ZIMMER, INC. N/A 62696852

    Patients

    Seq Age Sex Outcome Treatment
    1