BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN 17MM HEIGHT SIZE C,D WITH LOCKING SCREW YELLOW ARTICULAR SURFACE

    MDR report key: 22371238 · Received July 1, 2025

    Report

    Report Number
    0001822565-2025-02264
    Event Type
    Injury
    Date Received
    July 1, 2025
    Date of Event
    June 5, 2025
    Report Date
    September 8, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00889024224971
    PMA / PMN Number
    K173057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - CONCOMITANT MEDICAL PRODUCTS: 00599401391 - FEMORAL COMPONENT - 62979655 00598800300 - TIBIAL COMPONENT - 63841425 00598801215 - STEM EXTENSION - 64946306 00598801215 - STEM EXTENSION - 64881601 66038973 - COPAL CEMENT - 98381023 66038973 - COPAL CEMENT - 98381023 66038973 - COPAL CEMENT - 96634967 66038973 - COPAL CEMENT - 96634967 G2: FOREIGN - EVENT OCCURRED IN AUSTRALIA. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; G3; G6; H1; H2; H3; H6; H11 VISUAL EXAMINATION OF THE PROVIDED IMAGES REVEALS THE EXPLANTED ARTICULAR SURFACE WITH ITS POST. NO DAMAGES ARE VISIBLE ON THE EXPLANTED ARTICULAR SURFACE. NO FURTHER ASSESSMENT CAN BE MADE. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. IMAGING FINDINGS: PHOTO OF COMPUTER SCREEN SHOWING AP VIEWS OF THE LEFT KNEE. TOTAL KNEE ARTHROPLASTY WITH CEMENTED CONSTRAINED FEMORAL AND TIBIAL COMPONENTS. SINGLE PARTIALLY THREADED SCREW IN THE MEDIAL AND LATERAL TIBIAL PLATEAU SUGGESTS PRIOR SURGERY OR ARTHROPLASTY. EVALUATION FOR UNDER OR OVERSTUFFING IS LIMITED ON A SINGLE AP VIEW CONED TO THE KNEE WITHOUT STANDING MECHANICAL AXIS RADIOGRAPHS OR THOSE WITH THE CONTRALATERAL SIDE. IMPRESSION: LEFT TOTAL KNEE ARTHROPLASTY WITHOUT RADIOGRAPHIC EVIDENCE OF HARDWARE LOOSENING OR FAILURE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THIS COMPLIANT CANNOT BE CONFIRMED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL KNEE ARTHROSCOPY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO STIFFNESS. IT WAS REPORTED THAT NO FURTHER 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
    1207067 NEXGEN 17MM HEIGHT SIZE C,D WITH LOCKING SCREW YELLOW ARTICULAR SURFACE PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. 64557449 00889024224971

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R SEE H10 NARRATIVE.