BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NEXGEN TIBIAL COMPONENT

    MDR report key: 11466682 · Received March 11, 2021

    Report

    Report Number
    0001822565-2021-00692
    Event Type
    Injury
    Date Received
    March 11, 2021
    Report Date
    March 11, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    NI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). KIM, YOUNG-HOO, PARK, JANG-WON, JANG, YOUNG-SOO (FEB 2021) 20-YEAR MINIMUM OUTCOMES AND SURVIVAL RATE OF HIGH-FLEXION VERSUS STANDARD TOTAL KNEE ARTHROPLASTY. THE JOURNAL OF ARTHROPLASTY, VOL. 36, ISSUE 2, PAGES 560-565. HTTPS://DOI.ORG/10.1016/J.ARTH.2020.07.084. CONCOMITANT DEVICES - UNKNOWN NEXGEN LPS ARTICULAR SURFACE CATALOG #: NI LOT #: NI, UNKNOWN NEXGEN LPS FEMORAL COMPONENT CATALOG #: NI LOT #: NI. REPORT SOURCE - FOREIGN: SOUTH KOREA. THE PRODUCT COULD NOT BE EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS THE LOT NUMBER ASSOCIATED WITH THE REPORTED EVENT IS UNKNOWN. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. INSUFFICIENT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT TWO (2) PATIENTS UNDERWENT KNEE ARTHROPLASTY REVISIONS TO ADDRESS ASEPTIC LOOSENING OF THE TIBIAL COMPONENT. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356568 UNKNOWN NEXGEN TIBIAL COMPONENT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R