BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATUNE CR LT MS INS SZ 8 8

    MDR report key: 16051311 · Received December 27, 2022

    Report

    Report Number
    1818910-2022-26058
    Event Type
    Injury
    Date Received
    December 27, 2022
    Date of Event
    December 11, 2022
    Report Date
    December 27, 2022
    Manufacturer
    DEPUY IRELAND - 3015516266
    Product Code
    JWH
    UDI-DI
    10603295541912
    PMA / PMN Number
    K211609
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LTK ON (B)(6) 2022, JUST SEVERAL DAYS AGO. HE HAS AN ATTUNE FIXED BEARING, MEDIAL STABILIZED CONSTRUCT WITH AFFIXIUM TIBIA. HE IS INFECTED. HE IS BEING REVISED FOR THE CONFIRMED INFECTION. AN IRRIGATION AND DEBRIDEMENT WAS PERFORMED AND THE POLY WAS EXCHANGED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449500 ATUNE CR LT MS INS SZ 8 8 KNEE IMPLANT - TIBIAL INSERT JWH DEPUY IRELAND - 3015516266 1518-20-808 M03H99 10603295541912

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention