BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP,TSV,4.1MM,SBM,11.5

    MDR report key: 12689360 · Received October 25, 2021

    Report

    Report Number
    0002023141-2021-02994
    Event Type
    Malfunction
    Date Received
    October 25, 2021
    Date of Event
    May 26, 2021
    Report Date
    March 18, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019232
    PMA / PMN Number
    K072589
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SIMILAR COMPLAINTS FOR IMPLANT INFECTION HAVE BEEN PREVIOUSLY INVESTIGATED. REFER TO ATTACHED SUMMARY INVESTIGATION. VISUAL AND DIMENSIONAL EVALUATIONS OF THE PREVIOUSLY RETURNED PRODUCT HAVE NOT IDENTIFIED OR SUGGESTED MANUFACTURING NON-CONFORMANCES. WHILE NON-CONFORMANCES WERE IDENTIFIED FOR SOME LOTS DURING MANUFACTURING RECORD REVIEWS, THE DOCUMENTED DISPOSITION ACTIONS FOR EACH DID NOT SUGGEST THE LIKELY RELEASE OF NON-CONFORMING PRODUCT. ZIMMER BIOMET QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCT. ADDITIONALLY, ALL DEVICE HISTORY RECORD REVIEWS VERIFIED THAT EACH IMPLANT WAS STERILIZED PER PROCEDURE FOR EVERY DEVICE. ALL COMPLAINT DATA USED FOR THE SUMMARY INVESTIGATION WAS FOUND TO BE CONFORMING AND DID NOT MEET CAPA/HHE/D/IE ESCALATION. THEREFORE, THERE WERE NO COMPLAINTS WHICH CONFIRMED A MANUFACTURING OR DESIGN RELATED ISSUE THAT DID OR COULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1230951). 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 (1230951) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. AS DOCUMENTED IN THE SUMMARY INVESTIGATION, CONTRIBUTING FACTORS FOR THE 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. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: G6: CHECKED "FOLLOW-UP." H3: CHANGED "NO" TO "YES."

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PATIENT WEIGHT UNKNOWN / NOT PROVIDED. 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 # 12 WAS REMOVED DUE TO INFECTION. THE PAIN AT THE IMPLANT SITE WAS FOUND 3 MONTHS AFTER IMPLANTATION. THE PATIENT CAME TO THE CLINIC FOR EXAMINATION AND THE INFLAMMATION WAS FOUND. THE IMPLANT WAS REMOVED FOR ANTI-INFLAMMATORY TREATMENT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1588317 IMP,TSV,4.1MM,SBM,11.5 DENTAL IMPLANT DZE ZIMMER DENTAL TSV4B11 1230951 00889024019232

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male Required Intervention