BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS COMPLETE FEM POR L LG+

    MDR report key: 12820078 · Received November 16, 2021

    Report

    Report Number
    1818910-2021-25175
    Event Type
    Injury
    Date Received
    November 16, 2021
    Date of Event
    October 26, 2021
    Report Date
    October 25, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    NJL
    UDI-DI
    10603295021797
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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: THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

    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.

    Description of Event or Problem · 0

    REVISION KNEE SURGERY FOR ASEPTIC LOOSENING OF FEMORAL, TIBIAL AND PATELLA IMPLANTS OF THE LEFT KNEE. BONE SCANS HIGHLIGHTED "HOT" ON THE ABOVE THREE COMPONENTS. THE IMPLANTS WERE EXPLANTED AND REPLACED WITH AN ATTUNE REVISION KNEE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1718289 LCS COMPLETE FEM POR L LG+ LCS COMPLETE : KNEE FEMORAL NJL DEPUY ORTHOPAEDICS INC US 1294-04-070 2967832 10603295021797

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention LCS COMP RP INSERT LG+ 10MM.| LCS COMPLETE FEM POR L LG+.| LCS COMPLETE M/B PAT POR LG+.| MBT POR TIBIAL TRAY SZ6.