BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE EF 10 MM THICKNESS

    MDR report key: 12675058 · Received October 21, 2021

    Report

    Report Number
    0001822565-2021-03083
    Event Type
    Malfunction
    Date Received
    October 21, 2021
    Report Date
    October 21, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K113369
    Removal / Correction Number
    ZFA 2014-67, Z-1052-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PERFORMED A VISUAL INSPECTION OF THE RETURNED ITEM AND FOUND IT TO EXHIBIT SIGNS OF REPEATED USE AND HAVE COMPONENTS DISASSEMBLED / MISSING. THE COMPONENTS WERE NOT RETURNED. THE DEVICE HISTORY RECORDS & RECEIVING INSPECTION REPORT WERE REVIEWED FOR DEVIATIONS AND/ OR ANOMALIES WITH NO DEVIATIONS/ ANOMALIES IDENTIFIED. MEDICAL RECORDS WERE NOT PROVIDED. THIS DEVICE IS CONFIRMED TO HAVE BEEN A PART OF A PREVIOUS CAPA (B)(4) INVESTIGATION. FIELD ACTION ZFA 2014-67 AND Z-1052-2015 WERE INITIATED TO RECOMMEND AGAINST USING ULTRASONIC CLEANING AS A STERILIZING TECHNIQUE FOR THESE DEVICES. THESE DEVICES WERE SUBSEQUENTLY RE-DESIGNED TO ACCOUNT FOR THIS FAILURE MODE WITH A NEW LOCKING MECHANISM. IT WAS DETERMINED THAT THESE DEVICES WERE MANUFACTURED PRIOR TO THIS DESIGN CHANGE. THE ROOT CAUSE IS CONSIDERED TO BE A PREVIOUSLY ADDRESSED DESIGN ISSUE. A CAPA WAS PREVIOUSLY INITIATED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TASP WAS FOUND FRACTURED WHEN IT WAS RETURNED TO THE OFFICE SHELF. NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1568273 TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE EF 10 MM THICKNESS PROSTHESIS, KNEE JDI ZIMMER BIOMET, INC. N/A 62356776

    Patients

    Seq Age Sex Outcome Treatment
    1