BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE CD 11 MM THICKNESS

    MDR report key: 7746770 · Received August 3, 2018

    Report

    Report Number
    0001822565-2018-04138
    Event Type
    Malfunction
    Date Received
    August 3, 2018
    Report Date
    March 4, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBH
    PMA / PMN Number
    PK172524
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2018 - 04135 -1, 0001822565 - 2018 - 04136 -1, 0001822565 - 2018 - 04137 -1, 0001822565 - 2018 - 04139 -1 AND 0001822565 - 2018 - 04140 -1. THE COMPLAINT SAMPLE WAS RETURNED AND EVALUATED AND THE REPORTED EVENT WAS CONFIRMED THROUGH PHYSICAL EVALUATION. THE MISSING COMPONENTS WERE NOT RETURNED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE IDENTIFIED. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO DESIGN ISSUE. FIELD ACTIONS WERE INITIATED TO RECOMMEND AGAINST USING ULTRASONIC CLEANING AS A STERILIZING TECHNIQUE FOR THESE DEVICES. THE DEVICE WAS SUBSEQUENTLY RE-DESIGNED TO ACCOUNT FOR THIS FAILURE MODE WITH A NEW LOCKING MECHANISM. IT WAS DETERMINED THAT THIS DEVICE WAS MANUFACTURED PRIOR TO THIS DESIGN CHANGE.IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). 0001822565 - 2018 - 04135, 0001822565 - 2018 - 04136, 0001822565 - 2018 - 04137, 0001822565 - 2018 - 04138, 0001822565 - 2018 - 04139, 0001822565 - 2018 - 04134. 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 THAT TASP SHIMS WERE WORN AND RETURNED MISSING ONE OR BOTH BALL BEARINGS. NO PATIENT INVOLVEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589998 TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE CD 11 MM THICKNESS TEMPLATE MBH ZIMMER BIOMET, INC. N/A 62391125

    Patients

    Seq Age Sex Outcome Treatment
    1