BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATUNE REV RP TIB BASE SZ 4 CEM

    MDR report key: 12954980 · Received December 7, 2021

    Report

    Report Number
    1818910-2021-27419
    Event Type
    Malfunction
    Date Received
    December 7, 2021
    Date of Event
    January 1, 2021
    Report Date
    December 7, 2021
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    NJL
    UDI-DI
    10603295042884
    PMA / PMN Number
    P830055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # ==> (B)(4) INVESTIGATION SUMMARY ==> NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. 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 MANUFACTURING RECORD EVALUATION (NC SEARCH) WAS PERFORMED FOR THE FINISHED DEVICE 150660004, LOT 9915805, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED. JE (B)(6) 2022

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SURGEON WAS IMPACTING THE REVISION TIBIAL COMPONENTS IN THE REVISION TIBIA CONSTRUCT SAT UP SEVERAL MM FROM WHERE THE TRIAL SAT WHEN CEMENTING. HE HAD TO REMOVE TIBIA CLEAR OUT ALL THE CEMENT THAT HE JUST MIXED FOR IMPLANTS BECAUSE IT HARDENED. WE HAD TO OPEN NEW TIBIAL COMPONENTS FOR PATIENT WHICH CAUSED A 35-40 MIN DELAY IN THE CASE. DOI: (B)(6) 2021, DOE: (B)(6) 2021, RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1853762 ATUNE REV RP TIB BASE SZ 4 CEM KNEE TIBIAL TRAY NJL DEPUY IRELAND - 9616671 1506-60-004 9915805 10603295042884

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ATTUNE CEMENTED STEM 14X50MM| ATUN TIB SLV M/L 29MM HALF POR| ATUNE REV RP TIB BASE SZ 4 CEM