BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,4.1MM,SBM,11.5

    MDR report key: 13724816 · Received March 10, 2022

    Report

    Report Number
    0002023141-2022-00624
    Event Type
    Injury
    Date Received
    March 10, 2022
    Date of Event
    August 26, 2021
    Report Date
    August 18, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K072589
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4).

    Additional Manufacturer Narrative · 0

    TWO (2) TSV4B11, IMP,TSV,4.1MM,SBM,11.5 (1241239 & 1247590) WERE RECEIVED FROM THE CUSTOMER, HOWEVER IT IS UNKNOWN WHICH LOT# CORRESPONDS TO THIS COMPLAINT. DHR & COMPLAINT HISTORY REVIEW DONE FOR THE RETURNED PRODUCTS: DHR REVIEW WAS COMPLETED FOR THE ASSOCIATED SUBJECT LOT NUMBERS 1241239, & 1247590. 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 REVIEW WAS PERFORMED FOR THE ASSOCIATED LOT NUMBERS 1241239 (OP# 150 - STR2), & 1247590 (OP# 150 - STR2) AND VERIFIED TO HAVE PASSED ALL STERILIZATION ACTIVITIES WITH NO ISSUES OR NONCONFORMITIES IDENTIFIED. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE ASSOCIATED LOT NUMBERS 1247590 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER 1241239 FOR SIMILAR EVENTS AND 1 OTHER RELEVANT COMPLAINT WAS IDENTIFIED, (B)(4). A COMPLAINT HISTORY REVIEW BY ITEM NUMBER WAS CONDUCTED FOR THE TSV4B11 DATING BACK TO 12 MONTHS FROM THE COMPLAINT NOTIFICATION DATE. THE COMPLAINT HISTORY REVIEW REVEALED THAT THERE ARE NO EXISTING NON-CONFORMANCES/CAPA/HHE/D/IE/PRODUCT HOLDS FOR THE REPORTED DEVICE RELATED TO THE REPORTED EVENT. DHR, STERILIZATION, AND COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED, AS THE SUBJECT LOT NUMBERS ASSOCIATED WITH THE REPORTED PRODUCTS ARE 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. JUNE POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENTS (BONE LOSS & INFECTION) OR PRODUCTS (TSV4B11). REVIEW COMPLETED UTILIZING KEYWORDS: MEDICAL: INFECTION & MEDICAL: BONE LOSS. 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 INVESTIGATION, NO MALFUNCTION OCCURRED UPON INVESTIGATION. THE REPORTED EVENTS REMAIN NON-VERIFIABLE AS THEY ARE A MEDICAL CONDITION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO INFECTION, BONE LOSS AND PAIN AT THE SITE. PATIENT WILL NOT RETURN FOR ADDITIONAL APPOINTMENTS.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE ORIGINAL COMPLAINT DESCRIPTION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1525697 IMP,TSV,4.1MM,SBM,11.5 DENTAL IMPLANT DZE ZIMMER DENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention