BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,3.7,13,MTX,MG

    MDR report key: 10690292 · Received October 16, 2020

    Report

    Report Number
    0002023141-2020-01687
    Event Type
    Injury
    Date Received
    October 16, 2020
    Report Date
    October 16, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019942
    PMA / PMN Number
    K101977
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY INVESTIGATION (B)(4). PATIENT IDENTIFIER: NOT PROVIDED. PATIENT WEIGHT: NOT PROVIDED. EVENT DATE: NOT PROVIDED. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER CONFIRMED THE UNK IMPLANT AS TSVTB13, LOT 1223374. UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THAT THE DEVICE WAS PREVIOUSLY FILED UNDER THE INCORRECT MFR NUMBER (0001038806 - 2020 - 01055) ON 3 AGO 2020. AS A RESULT, THE EVENT HAS BEEN REASSESSED AND IS BEING FILED UNDER THE CORRECT MFR NUMBER (0002023141- 2020 - 01687). INVESTIGATION RESULTS HAVE BEEN COMPLETED AND ATTACHED BELOW. 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 (1223374). 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# (B)(4)) 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 (1223374) FOR SIMILAR EVENT 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. SUMMARY INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMPLANT (TSVTB13) WAS REMOVED DUE TO INFECTION. EVENT HAS BEEN PREVIOUSLY SUBMITTED UNDER THE INCORRECT MANUFACTURING SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1158362 IMP,TSV,3.7,13,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL TSVTB13 1223374 00889024019942

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention