BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATUN TIB SLV M/L 29MM HALF POR

    MDR report key: 15526017 · Received October 1, 2022

    Report

    Report Number
    1818910-2022-19297
    Event Type
    Injury
    Date Received
    October 1, 2022
    Date of Event
    September 15, 2022
    Report Date
    October 1, 2022
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    NJL
    UDI-DI
    10603295419624
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). INVESTIGATION SUMMARY: THE DEVICE ASSOCIATED WITH THIS COMPLAINT WAS NOT RETURNED. PHOTO EVIDENCE OF X-RAYS PROVIDED WAS REVIEWED AND NO PRODUCT ISSUE WAS IDENTIFIED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: A SEARCH OF THE DEPUY NONCONFORMANCE (NC) QUALITY SYSTEM FOUND 1 NC ASSOCIATED WITH THIS PRODUCT CODE 151111101 /LOT CODE J68W64 COMBINATION. HOWEVER THE NC IS NOT RELATED TOT HE CURRENT REPORTED ALLEGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IMPLANTS WERE INSERTED ON 2 DIFFERENT DATES AS A PARTIAL REVISION WAS PERFORMED ON THE SECOND DATE, (B)(6) 2021. A DER WAS SUBMITTED AT THAT TIME. FIRST 3 ITEMS LISTED WERE LEFT FROM (B)(6) 2020 PROCEDURE, THE REST WERE PLACED IN MAY 21. PATIENT COMPLAINED OF TIBIAL PAIN. XRAYS APPEARED TO HAVE LUCENCIES ON THE TIBIAL SIDE SO A TIBIAL SIDE REVISION WAS PLANNED. INSERT AND FEMORAL COMPONENT WERE REMOVED FOR EXPOSURE, THEN TIBIAL TRAY AND STEM WERE REMOVED, BUT THE TIBIAL SLEEVE WAS FOUND TO BE WELL FIXED. THE SURGEON WANTED TO SHORTEN THE ADAPTER ON THE FEMORAL SLEEVE AND WHEN TRYING TO REMOVE THE ADAPTER THE FEMORAL SLEEVE AND STEM WERE EXTRACTED. AT THIS POINT, A TIBIAL AND FEMORAL REVISION WERE PERFUMED UNEVENTFULLY. THERE WAS NO PATIENT HARM. DOI: (B)(6) 2020. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2171754 ATUN TIB SLV M/L 29MM HALF POR KNEE TIBIAL TRAY ACCESSORY NJL DEPUY IRELAND - 9616671 1511-11-101 J68W64 10603295419624

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Required Intervention ATTUNE REV LPS INSRT XSM 12MM| ATUNE PRESSFIT STR STEM12X60MM| ATUNE REV RP TIB BASE SZ 2 CEM| CONTROL CABLE W/CABLE SLEEVE| LPS DISTAL FEM COMP XSM RT| LPS FEM TO SLEEVE ADAPTER +5| UNIVERSAL FEM SLV FUL POR 31MM| UNIVERSAL STEM 75X14MM FLUTED