BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERSONA TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM

    MDR report key: 5914288 · Received August 30, 2016

    Report

    Report Number
    0001822565-2016-03014
    Event Type
    Malfunction
    Date Received
    August 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
    NJ, 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

    VISUAL EVALUATION CONCLUDES THAT THE RETURNED SHIM HAVE BOTH OF COMPONENTS 1 AND 2 DISASSEMBLED / MISSING NONE OF THE MISSING / DISASSEMBLED COMPONENTS. IT WAS PREVIOUSLY 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 IS TO BE ABLE TO WITHSTAND ULTRASONIC CLEANING WHICH WAS NOT IDENTIFIED DURING DEVELOPMENT. ZIMMER INITIATED A FIELD ACTION ON (B)(6) 2014. THE INSTRUMENT WAS MANUFACTURED BEFORE THE RECALL WAS LAUNCHED 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 PROVISIONAL SHIMS WERE RETURNED WITH MISSING BALL BEARINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565770 PERSONA TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM KNEE PROVISIONAL JWH ZIMMER, INC. 62102089

    Patients

    Seq Age Sex Outcome Treatment
    1