BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JRNY II BCS XLPE ART ISRT SZ 1-2 RT 11MM

    MDR report key: 9921364 · Received April 3, 2020

    Report

    Report Number
    1020279-2020-01132
    Event Type
    Malfunction
    Date Received
    April 3, 2020
    Date of Event
    March 4, 2020
    Report Date
    June 12, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    UDI-DI
    00885556178768
    PMA / PMN Number
    K111711
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SMITH & NEPHEW, INC. IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED UPON INFORMATION WHICH SMITH & NEPHEW, INC. HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, SMITH & NEPHEW, INC., OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SMITH & NEPHEW, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY, THE INSERT CANNOT BE INSERTED FULLY ONTO THE BASEPLATE. THE INSERT WAS SLIDING ONTO THE BASEPLATE, A RESISTANCE WAS FELT BY THE SURGEON AND IT DIDN'T FEEL SMOOTH, THE ANTERIOR SIDE OF THE INSERT WAS NOT SAT FULLY ONTO THE BASEPLATE, ALSO IT WAS NOT FIT OR LOCKED. IT CAUSED 10 MINUTES DELAY OF SURGERY. AN ALTERNATIVE DEVICE, S&N 12MM INSERT, WAS USED TO FINISH THE SURGERY. NO INJURY REPORTED NOR ADDITIONAL BONE CUTS WERE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385047 JRNY II BCS XLPE ART ISRT SZ 1-2 RT 11MM PR, KNEE, PTLLFMRTIBIAL, SMI-CNSTRD, CMNTD, PLYMR/MTL/PLYMR JWH SMITH & NEPHEW, INC. 74027213 18GM18806 00885556178768

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR