BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE TIBIAL TRAY

    MDR report key: 9184034 · Received October 14, 2019

    Report

    Report Number
    1818910-2019-109492
    Event Type
    Injury
    Date Received
    October 14, 2019
    Date of Event
    July 1, 2014
    Report Date
    September 26, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT : NULL. DEVICE HISTORY BATCH : NULL. DEVICE HISTORY REVIEW : NULL. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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. (B)(4).

    Description of Event or Problem · 1

    LITERATURE ARTICLE ENTITLED "WHAT CAN BE LEARNED FROM MINIMUM 20-YEAR FOLLOWUP STUDIES OF KNEE ARTHROPLASTY?" LITERATURE ARTICLE "WHAT CAN BE LEARNED FROM MINIMUM 20-YEAR FOLLOWUP STUDIES OF KNEE ARTHROPLASTY?" (2014) BY JOHN J. CALLAGHAN MD, CHRISTOPHER T. MARTIN MD, YUBO GAO PHD, ANDREW J. PUGELY MD, STEVE S. LIU MD, DEVON D. GOETZ MD, SCOTT S. KELLEY MD, AND RICHARD C. JOHNSTON MD PUBLISHED BY THE ASSOCIATION OF BONE AND JOINT SURGEONS DOI: 10.1007/S11999-014-3744-1 WAS REVIEWED FOR MDV REPORTABILITY. THE ARTICLE PURPOSE: TO EXAMINE THE RESULTS AT 20-YEAR FOLLOWUP OF TWO PROSPECTIVELY FOLLOWED KNEE ARTHROPLASTY COHORTS IN ORDER TO BETTER UNDERSTAND RELEVANT DIFFERENCES BETWEEN THE TWO COHORTS. THE ARTICLE REPORTS: THE STUDY'S TWO COHORTS INCLUDE ONE GROUP RECEIVING A PFC MODULAR TIBIAL TRAY (101 KNEES) AND ONE RECEIVING AN LCS ROTATING PLATFORM (119 KNEES). DEMOGRAPHICS OF THE COHORTS WERE SIMILAR. ALL PATIENTS WERE FOLLOWED LONGITUDINALLY FOR OVER 20 YEARS OR UNTIL DEATH. AFTER 20 YEARS, FOLLOW UP WAS CONDUCTED AND IT WAS FOUND THAT THE REVISION RATES FOR BOTH GROUPS WERE EXTREMELY LOW. IN THE PFC GROUP, THE REVISION RATE WAS 6% (6 KNEES). IN THE LCS GROUP, THE REVISION RATE WAS 0% (0 KNEES). THE REASON FOR REVISION SURGERIES WAS NOTED TO BE LOOSENING. MORTALITY RATES WERE ALSO GIVEN FOR EACH GROUP (75% FOR PFC; 74% FOR LCS) ALTHOUGH THIS IS TO BE EXPECTED WITH A LONG TERM FOLLOW UP STUDY SUCH AS THIS. REASONS AND TIMES OF DEATHS ARE NOT OUTLINED IN THIS ARTICLE. PATELLAR RESURFACING WAS CONDUCTED ROUTINELY FOR THE LCS COHORT. CEMENT WAS USED IN THE LCS KNEES ALTHOUGH THE CEMENT MANUFACTURER IS NOT DETAILED. DEPUY PRODUCTS INVOLVED: LCS RP SYSTEM AND THE PFC SYSTEM (ALTHOUGH NO ADVERSE EVENTS REPORTED WITH THE LCS KNEES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    978858 UNKNOWN KNEE TIBIAL TRAY KNEE TIBIAL TRAY JWH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1