BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NEXGEN LCCK TIBIAL COMPONENT

    MDR report key: 24759170 · Received April 1, 2026

    Report

    Report Number
    0001822565-2026-01056
    Event Type
    Injury
    Date Received
    April 1, 2026
    Report Date
    April 1, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). GREENBERG, A., BRAUNSTEIN, D., ABUGHADUMA, N.R., GROSS, A., SAFIR, O., KUZYK, P., WOLFSTADT, J., BACKSTEIN, D. (2025). SURVIVORSHIP AND COMPLICATIONS IN REVISION TOTAL KNEE ARTHROPLASTY WITH A CONSTRAINED CONDYLAR KNEE IMPLANT: A MINIMUM 10-YEAR FOLLOW-UP STUDY. THE JOURNAL OF ARTHROPLASTY 40 (12) 3240 - 3245 HTTPS://DOI.ORG/10.1016/J.ARTH.2025.05.088. D10 - CONCOMITANT DEVICES - UNKNOWN NEXGEN LCCK FEMORAL COMPONENT CATALOG #: NI LOT#: NI, UNKNOWN NEXGEN LCCK ARTICULAR SURFACE CATALOG#: NI LOT#: NI. G2: FOREIGN - EVENT OCCURRED IN CANADA. 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 MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH A JOURNAL ARTICLE THAT SEVEN (7) PATIENTS UNDERWENT KNEE ARTHROPLASTY REVISIONS TO ADDRESS ASEPTIC LOOSENING POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816123 UNKNOWN NEXGEN LCCK TIBIAL COMPONENT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H SEE H11 NARRATIVE.