BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA-DIAL/COMP TI STD TAPER

    MDR report key: 11331592 · Received February 16, 2021

    Report

    Report Number
    0001825034-2021-00494
    Event Type
    Injury
    Date Received
    February 16, 2021
    Report Date
    June 24, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    K080642
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2021-00492-1 0001825034-2021-00493-1 THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; G3; G6; H1; H2; H3 AFTER REASSESSMENT OF COMPLAINT AFTER DUE DILIGENCE THIS COMPLAINT HAS BEEN DETERMINED NOT REPORTABLE AND NEEDS TO BE VOIDED. THERE WERE NO ALLEGED PRODUCT DEFICIENCIES OR ISSUES THAT CONTRIBUTED TO THE ABANDONMENT OF THE PRIMARY PLAN, AND THERE ARE NO ALLEGED DEFICIENCIES WITH THE PRODUCTS THAT ARE CURRENTLY PLACED.

    Description of Event or Problem · 0

    AFTER REASSESSMENT OF COMPLAINT AFTER DUE DILIGENCE THIS COMPLAINT HAS BEEN DETERMINED NOT REPORTABLE AND NEEDS TO BE VOIDED. THERE WERE NO ALLEGED PRODUCT DEFICIENCIES OR ISSUES THAT CONTRIBUTED TO THE ABANDONMENT OF THE PRIMARY PLAN, AND THERE ARE NO ALLEGED DEFICIENCIES WITH THE PRODUCTS THAT ARE CURRENTLY PLACED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: COMP PRIMARY STEM 10MM MICRO CAT# 113610 LOT# 203410, VERSA-DIAL 50X27X50 HUM HEAD CAT# 113057 LOT# 060610. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2021-00492, 0001825034-2021-00493.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT IS EXPERIENCING INTENSE PAIN APPROXIMATELY 10 MONTHS¿ POST IMPLANTATION. NO REVISION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228464 VERSA-DIAL/COMP TI STD TAPER PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 732570

    Patients

    Seq Age Sex Outcome Treatment
    1 Other