BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CRUCIATE RETAINING FEMORAL COMPONENT RIGHT 75MM

    MDR report key: 24118970 · Received January 20, 2026

    Report

    Report Number
    0001825034-2026-00169
    Event Type
    Injury
    Date Received
    January 20, 2026
    Report Date
    April 7, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K023546
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - CONCOMITANT DEVICES - BIOMET POLISHED FINNED TIBIAL TRAY 83MM CATALOG #: 141256 LOT #: 2120007393, VANGUARD ANTERIOR STABILIZED TIBIAL BEARING 10MM X 83MM CATALOG #: 189120 LOT #: 66151333. G2 - REPORT SOURCE - FOREIGN: EVENT OCCURRED IN RUSSIA. 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 DEVICE REMAINS IMPLANTED. 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: A1, A2, A3, A4, B4, B5, B6, B7, D6A, G3, G6, H2, H6, H10, H11.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNKNOWN COMPLICATIONS FOLLOWING RIGHT KNEE ARTHROPLASTY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAS BEEN RECOMMENDED TO UNDERGO A RIGHT KNEE ARTHROPLASTY REVISION APPROXIMATELY THREE (3) MONTHS POST-OPERATIVELY TO ADDRESS CONTINUED INSTABILITY, SEVERE VARUS DEFORMITY, TIBIAL COMPONENT SUBLUXATION, LIMITED FLEXION AND CREPITUS. THE PATIENT HAS UNDERGONE PHYSIOTHERAPY, MAGNETIC THERAPY, LASER THERAPY, MASSAGE AND UTILIZES A KNEE BRACE AND CANE FOR WALKING. INITIAL OPERATIVE NOTES NOTED NO INTRAOPERATIVE COMPLICATIONS. HOWEVER, THE PATIENT'S DISCHARGE SUMMARY NOTED THAT THE PATIENT'S KNEE JOINT WAS DEFORMED AND DEFLECTED WITH SEVERE VARUS DEFORMITY OF THE LOWER EXTREMITY NOTED. THE PATIENT WAS NOTED TO HAVE PRESERVED ACTIVE KNEE MOTION, BUT WAS SIGNIFICANTLY LIMITED WITH MODERATE HYPOTROPHY OF THE THIGH, A PRONOUNCED CRUNCHING SOUND WITH MOVEMENT AND PAIN. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15374 VANGUARD CRUCIATE RETAINING FEMORAL COMPONENT RIGHT 75MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A J7527841

    Patients

    Seq Age Sex Outcome Treatment
    1