BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NEXGEN FEMORAL COMPONENT

    MDR report key: 22195267 · Received June 12, 2025

    Report

    Report Number
    0001822565-2025-01893
    Event Type
    Injury
    Date Received
    June 12, 2025
    Date of Event
    December 9, 2024
    Report Date
    July 21, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). IRMOLA, T., REITO, A., KANGAS, J. ESKELINEN, A., NIEMELAINEN, M., MATTILA, V. M., MOILANEN (2024) ASSESSMENT OF IMPROVEMENT IN FUNCTIONAL OUTCOMES BETWEEN A NOVEL KNEE REPLACEMENT DESIGN AND CONVENTIONAL DESIGNS IN 240 PATIENTS: A RANDOMIZED CONTROLLED TRIAL. ACTA ORTHOPAEDICA 2025 96, 127¿134. HTTPS://DOI.ORG/10.2340/17453674.2024.42708. B3 - EVENT DATE - JOURNAL ARTICLE PUBLICATION DATE. D10 - CONCOMITANT DEVICES - UNKNOWN NEXGEN TIBIAL COMPONENT CATALOG #: NI LOT #: NI, UNKNOWN NEXGEN ARTICULAR SURFACE CATALOG #: NI LOT #: NI. E1 - CONTACT - JOURNAL ARTICLE CORRESPONDENCE AUTHOR. G2 - REPORT SOURCE - FOREIGN: EVENT OCCURRED IN FINLAND. H6 - COMPONENT CODE - PROPOSED CODE IS MECHANICAL (G04) - FEMUR. THE COMPLAINANT HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE LOCATION OF THE DEVICE IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, G3, G6, H2, H6, H11. D4 - ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION AND NO FURTHER INFORMATION HAS BEEN PROVIDED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONE (1) PATIENT UNDERWENT A KNEE ARTHROPLASTY REVISION WITHIN TWELVE (12) MONTHS POST-OPERATIVELY TO ADDRESS UNKNOWN COMPLICATIONS. THE PATIENT WAS LOST TO FOLLOW UP AND NO FURTHER PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1361015 UNKNOWN NEXGEN FEMORAL COMPONENT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R SEE H11 NARRATIVE