BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKOWN ZIMMER BIOMET IMPLANT

    MDR report key: 11671786 · Received April 15, 2021

    Report

    Report Number
    0001038806-2021-00610
    Event Type
    Injury
    Date Received
    April 15, 2021
    Date of Event
    November 12, 2020
    Report Date
    July 9, 2021
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION AND DEVICE EVALUATION. DENTAL IMPLANT INFECTION IS A WELL-DOCUMENTED, PREVIOUSLY INVESTIGATED FAILURE WHICH IS CURRENTLY TRENDED ON A MONTHLY BASIS. CURRENT IMPLANT DESIGN AND MANUFACTURING RISK DOCUMENTATION ASSESS DENTAL IMPLANT INFECTIONS AS POTENTIAL FAILURES WITH ADEQUATE CONTROLS IN PLACE. THE PROCESS CONTROLS IN PLACE DEMONSTRATE THAT THE GAMMA STERILIZATION AND MANUFACTURING/PACKAGING PROCESSES ARE CONTROLLED AND ROBUST AND ARE UNLIKELY TO RESULT IN THE RELEASE OF NON-CONFORMING PRODUCT TO THE FIELD. THE DESIGN CONTROLS ALSO DEMONSTRATE THAT THE IMPLANT DESIGN IS UNLIKELY TO CAUSE OR CONTRIBUTE TO AN INFECTION OF A DENTAL IMPLANT. ADDITIONALLY, STERILIZATION VERIFICATION AND/OR VALIDATION ACTIVITIES ARE COMPLETED FOR EACH HAZARDOUS SITUATION ASSOCIATED WITH IMPLANT INFECTION, DEMONSTRATING THAT THE EXISTING CONTROLS IN PLACE MITIGATE ALL HAZARDS TO AN ACCEPTABLE LEVEL. DHR, STERILIZATION, AND COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED, AS THE SUBJECT LOT NUMBER ASSOCIATED WITH THE REPORTED PRODUCT IS NOT AVAILABLE. ZIMMER BIOMET QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO PREVENT THE DISTRIBUTION OF NON-CONFORMING PRODUCT AND ENSURE THE PRODUCT IS WITHIN SPECIFICATIONS. APRIL POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR DEVICE. AS DOCUMENTED IN THE SUMMARY INVESTIGATION, CONTRIBUTING FACTORS FOR THIS REPORTED EVENT LIKELY EXIST OUTSIDE OF ZIMMER BIOMET CONTROL, INCLUDING THOSE RELATED TO PATIENT BIOLOGICAL FACTORS/CONDITION AND SURGICAL TECHNIQUE. BASED ON THE SUMMARY INVESTIGATION, NO MALFUNCTION OCCURRED UPON INVESTIGATION. THE REPORTED EVENT REMAINS NON-VERIFIABLE AS IT IS A MEDICAL CONDITION.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). AGE AND DATE OF BIRTH UNKNOWN / NOT PROVIDED. WEIGHT UNKNOWN / NOT PROVIDED. LOT NUMBER UNKNOWN / NOT PROVIDED. LAST/GIVEN NAME UNKNOWN / NOT PROVIDED. PMA/510(K) NUMBER NOT AVAILABLE. A SUMMARY INVESTIGATION HAS BEEN COMPLETED FOR INFECTION EVENTS IDENTIFYING THAT A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED DUE TO THE WIDE RANGE OF EXTERNAL (NON-DESIGN/ NON-MANUFACTURING RELATED) FACTORS POTENTIALLY IMPACTING THE STERILITY OF THE IMPLANT AND ITS ENVIRONMENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED WHICH INDICATES THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE INFECTION EVENT, AN ADDITIONAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 27 WAS REMOVED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572553 UNKOWN ZIMMER BIOMET IMPLANT DENTAL IMPLANT DZE BIOMET 3I

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention