BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS COMPLETE FEM POR R STD+

    MDR report key: 6308498 · Received February 7, 2017

    Report

    Report Number
    1818910-2017-12059
    Event Type
    Injury
    Date Received
    February 7, 2017
    Date of Event
    January 25, 2017
    Report Date
    January 25, 2017
    Manufacturer
    DEPUY IRELAND 9616671
    Product Code
    JWH
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND ONE ADDITIONAL UNRELATED REPORT AGAINST THE MBT POR KEEL TIB TRAY SZ5 PRODUCT CODE 129434150, LOT CODE 3162886 COMBINATION. THE ADDITIONAL REPORT ((B)(4)) WAS FOR THE PATIENT BEING REVISED TO ADDRESS PAIN, AND IS NOT CONSIDERED RELATED TO THE CURRENT REPORTED PATIENT REVISION DUE TIBIAL LOOSENING AND FEMORAL MALPOSITIONING. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER RELATED REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT/LOT COMBINATIONS SINCE RELEASE FOR DISTRIBUTION. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. 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. CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    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. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS TIBIAL LOOSENING AND FEMORAL MALPOSITIONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90808 LCS COMPLETE FEM POR R STD+ KNEE FEMORAL COMPONENT JWH DEPUY IRELAND 9616671 3186164

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention