BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS COMPLETE FEM POR L LG+

    MDR report key: 12051376 · Received June 23, 2021

    Report

    Report Number
    1818910-2021-13391
    Event Type
    Injury
    Date Received
    June 23, 2021
    Date of Event
    June 8, 2021
    Report Date
    June 8, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    NJL
    UDI-DI
    10603295021797
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY 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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO EXTENSION TO THE SURGICAL TIME.

    Additional Manufacturer Narrative · 1

    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 · 1

    PATIENT UNDERWENT PRIMARY LEFT TKR ON (B)(6) 2016 WHERE AN UNCEMENTED LCS FEMORAL COMPONENT AND AN UNCEMENTED LCS TIBIAL COMPONENT WERE UTILIZED. PATIENT HAS REPORTED THAT THE KNEE HAS NEVER FELT RIGHT AND HAS HAD ONGOING LOW LEVELS OF DISCOMFORT. PATIENT HAS PRESENTED TO THE GOLD COAST UNIVERSITY HOSPITAL FOLLOWING A BUMP TO THE KNEE WITH SUBSEQUENT PAIN AND SWELLING. THE KNEE APPEARED TO BE INFECTED. A WASHOUT WAS PERFORMED (DATE AND SURGEON UNKNOWN) AND SAMPLES TAKEN. STAPH WAS GROWN/ CULTIVATED. A DECISION WAS MADE TO REMOVE THE CURRENT KNEE AS PART OF A TWO STAGE PROCEDURE. THE KNEE WAS OPENED AND THE INFECTION APPEARED OBVIOUS WITH PUSS PRESENT. THE LCS WAS REMOVED, THE KNEE DEBRIDED AND WASHED OUT SEVERAL TIMES. AN ATTUNE CR FEMORAL COMPONENT WAS LOOSELY CEMENTED IN ALONG WITH AN ATTUNE CR RP INSERT IN ORDER TO ACT AS A TEMPORARY SPACER. THE PLAN IS TO REMOVE THE SPACER IN APPROXIMATELY 8 WEEKS DOR: (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948779 LCS COMPLETE FEM POR L LG+ LCS COMPLETE : KNEE FEMORAL NJL DEPUY ORTHOPAEDICS INC US 1294-04-070 8364304 10603295021797

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention DEPUY DUOFIX MBT TRAY SZ 5| LCS COMP RP INSERT LG+ 10MM| DEPUY DUOFIX MBT TRAY SZ 5| LCS COMP RP INSERT LG+ 10MM