BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUST 10MM RS AVL YOKE

    MDR report key: 24924004 · Received April 20, 2026

    Report

    Report Number
    0001825034-2026-00965
    Event Type
    Injury
    Date Received
    April 20, 2026
    Report Date
    April 20, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: PN: CP111207 LN: 885120 CUSTOM AVL TIBIAL BUSHING SET PN: CP561286 LN: 883640 9MM SHORT CPS ANCHOR PLUG PN: CP115759 LN: 077630 9X25MM 400LB SHRT CPS SPDL PN: CP114019 LN: 885170 10MM RS AVL TIB BRNG PN: CP115761 LN: 077530 CUST 10MM RS AVL YOKE. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT IS BEING CONSIDERED FOR A REVISION DUE TO DECREASED RANGE OF MOTION. NO REVISION HAS BEEN REPORTED TO DATE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    982891 CUST 10MM RS AVL YOKE PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. 077530

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other SEE H11