BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP TM 4.1MM MTX FULL,13M

    MDR report key: 10345896 · Received July 30, 2020

    Report

    Report Number
    0002023141-2020-01139
    Event Type
    Malfunction
    Date Received
    July 30, 2020
    Report Date
    October 20, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K132258
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS ARE BEING REPORTED: H6: METHOD CODE WAS ADDED: 3331 AND 4109. H6: RESULTS CODE WAS ADDED: 3252. H6: CONCLUSIONS CODE WAS ADDED: 4307. THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION. THE REPORTED CONDITION OF A FRACTURED IMPLANT WAS CONFIRMED. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED SIGNS OF DEBRIS IN THE TM SHELL. THE BOTTOM PORTION OF THE IMPLANT WAS NOT RETURNED. THE DEVICE IS FRACTURED AT THE WELD. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE AND EVENT. A DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR THE REPORTED DEVICE LOT. IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO DEVIATIONS OR NON-CONFORMANCE, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT WAS NOTED AS PART OF THE DHR. A COMPLAINT HISTORY REVIEW WAS COMPLETED FOR THE REPORTED DEVICE LOT FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET (B)(4). PATIENT IDENTIFIER IS NOT PROVIDED / UNKNOWN. PATIENT AGE IS NOT PROVIDED / UNKNOWN. PATIENT WEIGHT IS NOT PROVIDED / UNKNOWN. DATE OF EVENT IS NOT PROVIDED / UNKNOWN. INITIAL REPORTER¿S TITLE, FIRST NAME, LAST NAME AND EMAIL ADDRESS ARE NOT PROVIDED / UNKNOWN. ADDITIONAL 510(K) NUMBERS ARE K113753 AND K112160.

    Description of Event or Problem · 1

    DOCTOR REPORTS THAT THE TMT4B13 IMPLANT FRACTURED UPON PLACEMENT. IMPLANT WAS REMOVED AND A NEW ONE PLACED IN THE SAME SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809757 IMP TM 4.1MM MTX FULL,13M DENTAL IMPLANT DZE ZIMMER DENTAL 63488967

    Patients

    Seq Age Sex Outcome Treatment
    1