BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS COMPLETE FEM POR R LG

    MDR report key: 4031123 · Received August 22, 2014

    Report

    Report Number
    1818910-2014-26447
    Event Type
    Injury
    Date Received
    August 22, 2014
    Date of Event
    June 11, 2013
    Report Date
    June 11, 2013
    Manufacturer
    DEPUY IRELAND 9616671
    Product Code
    NJL
    PMA / PMN Number
    PP830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PROVIDED PRODUCT/LOT CODE COMBINATIONS. REVIEW OF DEVICE HISTORY RECORDS FINDS NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF PROVIDED PATIENT X-RAYS CANNOT DETERMINE ANY PRODUCT CONTRIBUTION TO THE PATIENT'S REPORTED INFECTION. THE PATIENT WAS PRIMARILY IMPLANTED IN (B)(6) 2012, REVISED FOR INFECTION IN (B)(6)2013, AND REIMPLANTED ON (B)(6) 2013. THE PATIENT IS A REPORTED (B)(6) MALE WITH A CALCULATED BMI OF (B)(6). THE PATIENT IS CONSIDERED OBESE. IT IS STATED IN THE WARNINGS AND PRECAUTIONS THAT EXCESSIVE PATIENT WEIGHT TEND TO ADVERSELY AFFECT KNEE REPLACEMENT IMPLANTS. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN 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

    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

    PRIMARY TKR ON (B)(6) 2012. BECAME INFECTED, ALL COMPONENTS REMOVED APPROXIMATELY 4 MONTHS AGO ACCORDING TO SURGEON (NO REP ATTENDED, AS NOT INFORMED OF PROCEDURE). ANTIBIOTIC SPACER INSITU DURING THESE LAST 4 MONTHS. REVISION PROSTHESIS IMPLANTED ON (B)(6) 2013 (B)(6). PATHOLOGY SPECIMENS TAKEN. PATIENT INITIALS, AGE, DOB, GENDER, HEIGHT AND WEIGHT ARE PROVIDED. XRAY PHOTOS ARE AVAILABLE. (B)(6) 2014 REOPENED AT REQUEST OF (B)(6) TO AMEND DATA IN COMPLAINT DESCRIPTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508810 LCS COMPLETE FEM POR R LG KNEE FEMORAL COMPONENT NJL DEPUY IRELAND 9616671 3461004

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention