BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP TM 4.1MM MTX FULL, 11.5MM

    MDR report key: 14397497 · Received May 13, 2022

    Report

    Report Number
    0002023141-2022-01190
    Event Type
    Malfunction
    Date Received
    May 13, 2022
    Date of Event
    April 4, 2022
    Report Date
    February 2, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024018945
    PMA / PMN Number
    K132258
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT (B)(4). PATIENT IDENTIFIER IS NOT PROVIDED / UNKNOWN. PATIENT AGE IS NOT PROVIDED / UNKNOWN. PATIENT WEIGHT IS NOT PROVIDED / UNKNOWN. INITIAL REPORTER¿S TITLE IS NOT PROVIDED / UNKNOWN. ADDITIONAL 510(K) NUMBERS ARE K11375 AND K112160.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO REPORT CORRECTED INFORMATION TO 0002023141 - 2022 - 01190 - 1. THE EMPTY PACKAGING WAS RETURNED FOR INVESTIGATION. BASED ON THE EVALUATION THE EVENT IS NON-VERIFIABLE AS THE PACKAGE WAS RETURNED IN OPENED CONDITION AND THE CONDITIONS OF THE PRODUCT WHEN IT WAS RECEIVED BY CUSTOMER ARE UNKNOWN / NON-VERIFIABLE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMVIE WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    THE PRODUCT (AND/OR PACKAGING) WAS NOT RETURNED FOR INVESTIGATION. THE REPORTED EVENT IS NON-VERIFIABLE. BASED ON THE EVALUATION, THE DEVICE MALFUNCTION COULD NOT BE VERIFIED. ADDITIONALLY, THERE IS NO EXISTING NONCONFORMANCE/CAPA/HHE/D/IE/PRODUCT HOLDS AGAINST THE REPORTED DEVICES THAT COULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. ZIMMER BIOMET QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCT. THEREFORE, BASED ON THE AVAILABLE INFORMATION, THE PRODUCTS WERE LIKELY WITHIN SPECIFICATIONS AND LIKELY CONFORMING WHEN THEY LEFT ZIMMER BIOMET. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER. IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT WAS NOTED AS PART OF THE DHR. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. THE REPORTED EVENT COULD NOT BE RECREATED DUE TO THE NATURE OF THE DENTAL DEVICE AND EVENT AND THE COMPLAINT IS RELATED TO THE FUNCTIONAL PERFORMANCE OF THE DEVICE. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. NO FURTHER INVESTIGATION AND NO IMMEDIATE CAPA/HHE/D ESCALATION IS REQUIRED, AS THE COMPLAINT INVESTIGATION DID NOT CONFIRM THE PRODUCT WAS NONCONFORMING AT THE TIME OF DISTRIBUTION, AND NO NEW FAILURE MODE, HARM, OR HAZARDOUS SITUATION WAS IDENTIFIED THROUGH THE INVESTIGATION PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT WAS MISSING FROM THE PACKAGE. CUSTOMER CONFIRMED ANOTHER IMPLANT WAS PLACED IN THE SAME SURGERY.

    Description of Event or Problem · 0

    NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.

    Description of Event or Problem · 0

    NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1836489 IMP TM 4.1MM MTX FULL, 11.5MM DENTAL IMPLANT DZE ZIMMER DENTAL TMT4B11 1238390 00889024018945

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose