BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE GH 10 MM

    MDR report key: 11307998 · Received February 10, 2021

    Report

    Report Number
    0001822565-2021-00353
    Event Type
    Malfunction
    Date Received
    February 10, 2021
    Report Date
    February 25, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K172524
    Removal / Correction Number
    ZFA 2014-67, Z-1052-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VERIFIED ITEM LOT COMBINATION AND REVIEWED MANUFACTURING DATE AS RETURNED ITEM EXHIBITS SIGNS OF REPEATED USE AND HAS ONE OF 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 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.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM THE WIR FORM THAT A PERSONA KNEE INSTRUMENT WAS RETURNED AND REPORTED MISSING BEARING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205652 TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE GH 10 MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 62320658

    Patients

    Seq Age Sex Outcome Treatment
    1