BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET SMOOTH KNEE STEM 16MM X 80MM

    MDR report key: 23943965 · Received January 2, 2026

    Report

    Report Number
    0001825034-2026-00003
    Event Type
    Injury
    Date Received
    January 2, 2026
    Report Date
    May 18, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00880304471337
    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 12MM X 40MM CATALOG #: 145002, LOT #: 66366323, 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
    468983 BIOMET SMOOTH KNEE STEM 16MM X 80MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 161830 00880304471337

    Patients

    Seq Age Sex Outcome Treatment
    1