BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,4.1,10,MTX,MG

    MDR report key: 12829509 · Received November 17, 2021

    Report

    Report Number
    0002023141-2021-03305
    Event Type
    Injury
    Date Received
    November 17, 2021
    Date of Event
    October 27, 2021
    Report Date
    April 30, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019829
    PMA / PMN Number
    K101977
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SIMILAR COMPLAINTS FOR INFECTION AND / OR BONE LOSS RELATED PROBLEMS HAVE BEEN PREVIOUSLY INVESTIGATED. REFER TO ATTACHED SUMMARY INVESTIGATION. INVESTIGATIONS PERFORMED FOR HUNDREDS OF EVENTS WHERE EITHER OF THESE CONDITIONS, INFECTION OR BONE LOSS, OR BOTH, HAVE BEEN REPORTED, HAVE CONCLUDED THAT THE LIKELY CAUSE(S) FOR THE IMPLANT FAILURE IN RELATION TO THESE CONDITIONS ARE EXTERNAL FACTORS. THOSE INCLUDE, MEDICAL CONDITIONS (E.G., DIABETES, BRUXISM, ETC.), PATIENT HABITS (E.G., SMOKING, BAD ORAL HYGIENE ROUTINE) AND USER ERROR (E.G., SURGICAL TECHNIQUE). THERE HAS NOT BEEN ANY INSTANCE WHERE EITHER INFECTION AND/OR BONE LOSS, HAVE RESULTED FROM A MANUFACTURING OR DESIGN DEFECT. FURTHERMORE, THE PROBABILITY OF MANUFACTURING OR DESIGN DEFECTS THAT MIGHT LEAD TO INFECTION AND RESULT IN BONE LOSS OCCURRING AND ESCAPING THE AVAILABLE DETECTIONS HAS BEEN ASSESSED AND FOUND REMOTE AND ALMOST NONEXISTENT. ZIMMER BIOMET QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCT. THE ANALYSIS AND RESULT OF INVESTIGATIONS AND THE ANALYSIS OF PROBABILITY PREVIOUSLY DESCRIBED ARE CONTAINED IN THE SUMMARY INVESTIGATION REPORTS PERFORMED FOR BONE LOSS AND INFECTION, WHICH ARE ATTACHED. 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 (1243611). 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 (1243611) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. AS DOCUMENTED IN THE SUMMARY INVESTIGATIONS, 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 INVESTIGATIONS, NO MALFUNCTION OCCURRED UPON INVESTIGATION. THE REPORTED EVENTS REMAIN NON-VERIFIABLE AS THEY ARE A MEDICAL CONDITION.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). WEIGHT UNKNOWN / NOT PROVIDED. A SUMMARY INVESTIGATION HAS BEEN COMPLETED FOR BONE LOSS AND INFECTION EVENTS RECOGNIZING THAT A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED DUE TO A WIDE RANGE OF EXTERNAL FACTORS (NON-DESIGN OR MANUFACTURING RELATED), INCLUDING MEDICAL CONDITIONS (E.G., DIABETES, POOR BONE QUALITY, ETC.) / PATIENT HABITS (E.G., SMOKING) AND SURGICAL TECHNIQUE. PREVIOUSLY COMPLETED INVESTIGATIONS FOR BONE LOSS AND INFECTION HAVE NOT IDENTIFIED ANY SIGNALS INDICATING POTENTIAL NON-CONFORMANCES AFFECTING THE MANUFACTURING AND STERILIZATION PROCESSES. FURTHERMORE, THE PROBABILITY OF MANUFACTURING OR DESIGN DEFECTS THAT MIGHT LEAD TO BONE LOSS AND ESCAPING THE AVAILABLE DETECTIONS HAS BEEN ASSESSED AND FOUND REMOTE AND ALMOST NONEXISTENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED WHICH INDICATES THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AN ADDITIONAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #13 WAS REMOVED DUE TO INFECTION & BONE LOSS. THE IMPLANT FAILED ABOUT 3 WEEKS AFTER PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1725822 IMP,TSV,4.1,10,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL TSVT4B10 1243611 00889024019829

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male Required Intervention