BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9X25MM 400LB SHRT CPS SPDL

    MDR report key: 24923941 · Received April 20, 2026

    Report

    Report Number
    0001825034-2026-00963
    Event Type
    Injury
    Date Received
    April 20, 2026
    Report Date
    April 20, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    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
    983353 9X25MM 400LB SHRT CPS SPDL PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. 077630

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other SEE H11.