BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET SMOOTH KNEE STEM 12MM X 40MM

    MDR report key: 23943954 · Received January 2, 2026

    Report

    Report Number
    0001825034-2026-00002
    Event Type
    Injury
    Date Received
    January 2, 2026
    Report Date
    May 18, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00880304459960
    PMA / PMN Number
    K171054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - CONCOMITANT DEVICES - VANGUARD SSK FEMORAL IMPLANT WITH SCREW 60MM LEFT CATALOG #: CP113123 LOT #: 66529561, BIOMET OFFSET TIBIAL TRAY 63MM CATALOG #: 141481 LOT #: 65745839, VANGUARD SSK TIBIAL BEARING 22MM X 63/67MM CATALOG #: 183832 LOT #: 929580, BIOMET SMOOTH KNEE STEM 16MM X 80MM CATALOG #: 145026 LOT #: 161830, PERSONA CEMENTED ALL POLY PATELLA 32MM CATALOG #: 42540000032 LOT #: 66187751, PERSONA TIBIAL CENTRAL CONE SIZE X-SMALL CATALOG #: 42545000510 LOT #: 66948841 H6 - COMPONENT CODE - PROPOSED CODE IS MECHANICAL (G04) - STEM. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN AND STIFFNESS APPROXIMATELY SIX (6) MONTHS FOLLOWING KNEE ARTHROPLASTY. INITIAL OPERATIVE NOTES NOTED NO INTRAOPERATIVE COMPLICATIONS. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50316 BIOMET SMOOTH KNEE STEM 12MM X 40MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 66366323 00880304459960

    Patients

    Seq Age Sex Outcome Treatment
    1