BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGMA XLK CVD+ INS 1.5 8MM

    MDR report key: 15969093 · Received December 13, 2022

    Report

    Report Number
    1818910-2022-25205
    Event Type
    Malfunction
    Date Received
    December 13, 2022
    Date of Event
    January 1, 2022
    Report Date
    December 13, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    UDI-DI
    10603295250371
    PMA / PMN Number
    K040166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: A MANUFACTURING RECORD EVALUATION (MRE), WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. 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 · 0

    ONE OF OUR CUSTOMERS, WHO USED SIGMA TIBIAL TRAY IN COCR VERSION SO FAR, FOR ECONOMIC REASONS HAD TO SWITCH TO A CHEAPER SOLUTION AND THAT IS FB MODULAR TITANIUM TRAY. AFTER THIS CHANGE HE CLAIMS THAT ONE TYPE OF INSERT DOES NOT FIT HIM IN THE TITANIUM TRAY AS WELL AS IN THE COCR TRAY - THIS IS THE SIGMA FB CURVED PLUS INSERT. CUSTOMER ASKING FOR CONFIRMATION OF THE COMPATIBILITY OF THE TWO ELEMENTS, I.E. SIGMA FB MODULAR TITANIUM TIBIAL TRAY (866022 ¿ 866029) IN COMBINATION WITH SIGMA FB CURVED PLUS INSERT (970420 ¿ 970485).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2297891 SIGMA XLK CVD+ INS 1.5 8MM SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT JWH DEPUY ORTHOPAEDICS INC US 97-0420 970485 10603295250371

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown