BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE CRS FB INSRT SZ 7 16MM

    MDR report key: 14655580 · Received June 10, 2022

    Report

    Report Number
    1818910-2022-10658
    Event Type
    Injury
    Date Received
    June 10, 2022
    Date of Event
    May 1, 2021
    Report Date
    June 10, 2022
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    JWH
    UDI-DI
    10603295055075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (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

    SUBJECT ID: (B)(6). STUDY: DSJ-2016-02 NEW CLINICAL ADVERSE EVENT RECEIVED FOR RIGHT KNEE LIMITED RANGE OF MOTION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2021. DATE OF EVENT: UNK (B)(6) 2021. (RIGHT KNEE). TREATMENT: AWAITING MANIPULATION UNDER ANESTHESIA

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2155622 ATTUNE CRS FB INSRT SZ 7 16MM KNEE TIBIAL INSERT JWH DEPUY IRELAND - 9616671 1517-00-716 10603295055075

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention ATTUN REV OFFST STM ADPTR 4MM| ATTUN REV OFFST STM ADPTR 4MM| ATTUNE CRS FB INSRT SZ 7 16MM| ATTUNE CRS FEMORAL RT SZ 7 CEM| ATTUNE DIST FEM AUG SZ 7 4MM| ATTUNE DIST FEM AUG SZ 7 4MM| ATTUNE MEDIAL DOME PAT 38MM| ATTUNE POS FEM AUG SZ 7 8MM| ATTUNE POS FEM AUG SZ 7 8MM| ATUN PRESSFIT STR STEM24X110MM| ATUNE CRS FB TIB BASE SZ 6 CEM| ATUNE PRESSFIT STR STEM22X60MM| COMPETITOR CEMENT MANUFACTURER (STRYKER)| COMPETITOR CEMENT MANUFACTURER (STRYKER)