BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS COMPLETE M/B PAT CEM STD

    MDR report key: 6544736 · Received May 4, 2017

    Report

    Report Number
    1818910-2017-17556
    Event Type
    Injury
    Date Received
    May 4, 2017
    Date of Event
    March 29, 2017
    Report Date
    April 12, 2017
    Manufacturer
    DEPUY (IRELAND) 9616671
    Product Code
    NJL
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    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 AT THIS TIME. SHOULD THE 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 · 1

    PATIENT WAS REVISED TO ADDRESS A LOOSE FEMORAL COMPONENT. LOOSENING OCCURRED AT THE BONE/CEMENT INTERFACE. CEMENT MANUFACTURED BY DEPUY. THE PATIENT'S MEDICAL RECORDS WERE RECEIVED. MEDICAL RECORDS WERE REVIEWED FOR MDR REPORTABILITY. ACCORDING TO THE MEDICAL RECORDS, THE PATIENT WAS EXPERIENCING PERSISTENT PAIN. NOTED UPON REVISION, THE PATIENT HAD SYNOVITIS AND SMALL FRAGMENTS OF CEMENT. ALSO NOTED, THE PATIENT HAD PATELLA INFERA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327504 LCS COMPLETE M/B PAT CEM STD KNEE PATELLAR COMPONENT NJL DEPUY (IRELAND) 9616671 3534114

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention