BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC*SIGMA/RD/DOME PAT 3PEG,35

    MDR report key: 9962552 · Received April 15, 2020

    Report

    Report Number
    1818910-2020-10785
    Event Type
    Injury
    Date Received
    April 15, 2020
    Date of Event
    February 14, 2018
    Report Date
    April 1, 2020
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    UDI-DI
    10603295232667
    Adverse Event
    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. 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

    (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

    MAUDE REPORT RECEIVED. IT WAS REPORTED THAT THE PATIENT HAD HER KNEES REPLACED: RIGHT ¿UNICOMPARTMENTAL¿ KNEE ARTHROPLASTY DONE IN 2002, LEFT TOTAL KNEE ARTHROPLASTY DONE IN 2003, AND CONVERSION OF RIGHT UNICOMPARTMENTAL TO TOTAL KNEE ARTHROPLASTY DONE IN 2003. THE RIGHT KNEE IMPLANT IS A DEPUY SIGMA KNEE WITH A STABILIZED 15MM TIBIAL INSERT SZ 2.5, (93-0053-500), SIGMA NON-POROUS RIGHT SZ 3 FEMORAL (112934, 96-0111), KNEE PATELLA 35MM ROUND 3 PEG ONSET UHMWPE PFC SIGMA, 1581-25-000, MOD TIBIAL TRAY CEMENTED. THE LEFT KNEE IMPLANT IS A DEPUY SIGMA TIBIAL POLY STAB#2 10MM (1024658, 96-0110), KNEE PATELLA PFC SIGMA ROUND/DOME 3 PEG 32MM, 96-0043-500, SIGMA NONPOROUS FEMORAL LEFT SZ 3. ALL THREE ARTIFICIAL JOINTS CONSIST OF COCR COMPONENTS. SHE CONTINUOUSLY DEVELOPED AN EFFUSION OF THE RIGHT REVISED TKA. COBALT AND CHROMIUM SYNOVIAL FLUID FROM RIGHT KNEE ASPIRATION DONE 2018, AND CHROMIUM LEVEL WAS 2.0 MCG/L AND COBALT LEVEL WAS NOT DETECTED. RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424930 PFC*SIGMA/RD/DOME PAT 3PEG,35 SIGMA KNEE PRIMARY : KNEE PATELLA JWH DEPUY ORTHOPAEDICS INC US 96-0111 10603295232667

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SIG MOD TIB TRAY CEM COCR 2.5| UNKNOWN KNEE FEMORAL| UNKNOWN KNEE TIBIAL INSERT