BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,6.0,13,MTX,MG

    MDR report key: 8735304 · Received June 26, 2019

    Report

    Report Number
    0002023141-2019-00335
    Event Type
    Injury
    Date Received
    June 26, 2019
    Date of Event
    May 29, 2019
    Report Date
    September 9, 2019
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K101977
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). SIMILAR COMPLAINTS FOR IMPLANT INFECTION HAVE BEEN PREVIOUSLY INVESTIGATED. 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 NONCONFORMING 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 (1220485). 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. STERILIZATION RECORD (OP#150) WAS REVIEWED AND VERIFIED TO HAVE PASSED ALL STERILIZATION ACTIVITIES WITH NO ISSUES OR NONCONFORMITIES IDENTIFIED. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1220485) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. AS DOCUMENTED IN THE SUMMARY INVESTIGATION, CONTRIBUTING FACTORS FOR THESE REPORTED EVENTS 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. PREVIOUSLY COMPLETED INVESTIGATIONS FOR THE INFECTION OF AN IMPLANT HAVE NOT IDENTIFIED ANY SIGNALS INDICATING POTENTIAL NON-CONFORMANCES IMPACTING THE MANUFACTURING AND STERILIZATION PROCESSES. WITH NO SIGNALS INDICATING A SYSTEMIC QUALITY ISSUE, NO ESCALATION TO CAPA IS REQUIRED. SEE ATTACHED SUMMARY INVESTIGATION.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMERBIOMET COMPLAINT NUMBER: (B)(4). ADDITIONAL PMA/510(K) NUMBERS: K101880. PRODUCT NOT RETURNED YET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO INFECTION. TOOTH LOCATION 6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527551 IMP,TSV,6.0,13,MTX,MG IMPLANT DZE ZIMMER DENTAL 1220485

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention