BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERSONA ARTICULAR SURFACE SHIM PROVISIONAL

    MDR report key: 5538927 · Received March 31, 2016

    Report

    Report Number
    1822565-2016-00831
    Event Type
    Malfunction
    Date Received
    March 31, 2016
    Report Date
    March 3, 2016
    Manufacturer
    ZIMMER INC
    Product Code
    JWH
    Removal / Correction Number
    Z-1052-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). OTHER DEVICE USED: CATALOG #42527900502, PERSONA ARTICULAR SURFACE SHIM PROVISIONAL, LOT #6241683. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    PRODUCT WAS RECEIVED FOR INSPECTION. VISUAL INSPECTION OF THE RETURNED PERSONA TIBIAL ARTICULAR SURFACE PROVISIONAL (TASP) SHIMS IDENTIFIED BOTH DEVICES WERE MISSING BOTH SPRINGS AND BALL BEARINGS. THIS LOT AND ASSOCIATED LOT WERE MANUFACTURED IN JULY 2013 AND JUNE 2013 RESPECTIVELY, WITH AN APPROXIMATE FIELD AGE OF 2 YEARS 8 MONTHS AND 2 YEARS 9 MONTHS, AND HAVE BEEN USED IN AN UNKNOWN NUMBER OF SURGERIES. THIS IS A KNOWN REPORTED ISSUE WHICH HAS BEEN INVESTIGATED THROUGH CORRECTIVE ACTIONS INVESTIGATIONS. THIS DEVICE IS USED FOR TREATMENT. CORRECTIVE ACTIONS INVESTIGATION HAS IDENTIFIED 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. A KNOWN FIELD NOTIFICATION CONTAINS ALL TASP SHIM LOTS. BASED ON THE INVESTIGATION, THE INSTRUMENT WAS MANUFACTURED BEFORE THE FILED NOTIFICATION 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 BALL BEARINGS ARE MISSING FROM THE INSTRUMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196120 PERSONA ARTICULAR SURFACE SHIM PROVISIONAL JWH JWH ZIMMER INC 62404289

    Patients

    Seq Age Sex Outcome Treatment
    1