BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    KYOCERA MEDICAL TECHNOLOGIES, INC

    MDR report key: 13565125 · Received February 19, 2022

    Report

    Report Number
    3015398319-2022-00001
    Event Type
    Malfunction
    Date Received
    February 19, 2022
    Date of Event
    January 20, 2022
    Report Date
    February 18, 2022
    Manufacturer
    KYOCERA MEDICAL TECHNOLOGIES, INC.
    Product Code
    OQI
    UDI-DI
    00841523102549
    PMA / PMN Number
    K112897
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED, AN EXPIRED HIP STEM WAS INADVERTENTLY IMPLANTED INTO THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY/INFECTION. NO REVISION SURGERY WAS REPORTED. THE EXPIRATION DATE IS LOCATED ON MULTIPLE LAYERS OF THE PACKAGING. THIS EVENT IS CONFIRMED AS A USER RELATED ERROR WITH NO MALFUNCTION OF THE DEVICE. REVIEW OF MANUFACTURING RECORDS CONFIRMS PRODUCT WAS MANUFACTURED TO SPECIFICATION AND THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURING, OR LABELING. TO DATE, THIS IS THE ONLY REPORTED COMPLAINT FROM THIS MANUFACTURING LOT RELEASED FOR DISTRIBUTION IN NOVEMBER 2016. SINCE THE EXPIRED PRODUCT REMAINS IMPLANTED IN THE PATIENT AND WILL NOT BE REVISED/RETURNED, THE PACKAGING OF 10 STEMS THAT EXPIRED ON THE SAME DATE AS THE SUBJECT STEM WAS TESTED. THE RESULTS OF THESE PACKAGING TESTS SHOWED THAT THE PACKAGING STILL RETAINED SUFFICIENT PACKAGE SEAL STRENGTH AND PACKAGE SEAL INTEGRITY POST EXPIRATION, IMPLYING THAT THE REPORTED STEM LIKELY ALSO RETAINED SUFFICIENT SEAL STRENGTH AND SEAL INTEGRITY POST EXPIRATION AT TIME OF IMPLANTATION. THIS PRODUCT COMPLAINT INVESTIGATION WILL BE INCLUDED IN AN ONGOING INTERNAL CAPA RELATED TO EXPIRED OR EXPIRING INVENTORY. SHOULD ADDITIONAL INFORMATION BE PROVIDED BY THE HEALTHCARE PROVIDER, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    EXPIRED IMPLANT WAS USED IN SURGERY ON (B)(6) 2022. IMPLANT EXPIRED ON 10/13/2021. IMPLANTATION WAS AN OVERSIGHT FROM BOTH THE SURGICAL REP. AND THE NURSE IN SURGERY WHO CALL OUT THE ITEMS BEING IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2407711 KYOCERA MEDICAL TECHNOLOGIES, INC TAPERED FEMORAL STEM, STD OFFSET, 10.5MM OQI KYOCERA MEDICAL TECHNOLOGIES, INC. A 400 2872-2 00841523102549

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown