BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE MEDIAL DOME PAT 38MM

    MDR report key: 14655663 · Received June 10, 2022

    Report

    Report Number
    1818910-2022-10659
    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
    NJL
    UDI-DI
    10603295056690
    PMA / PMN Number
    P830055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. 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. AFFECTED SIDE: (RIGHT KNEE). TREATMENT: AWAITING MANIPULATION UNDER ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630681 ATTUNE MEDIAL DOME PAT 38MM ATTUNE IMPLANT : KNEE PATELLA NJL DEPUY IRELAND - 9616671 1518-20-038 9485121 10603295056690

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female 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)