BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PSN ASF CR 10MM VE R 3-11 EF

    MDR report key: 23693389 · Received December 2, 2025

    Report

    Report Number
    3007963827-2025-00480
    Event Type
    Malfunction
    Date Received
    December 2, 2025
    Date of Event
    November 7, 2025
    Report Date
    April 16, 2026
    Manufacturer
    ZIMMER ORTHOPAEDIC MFG. LTD.
    Product Code
    MBH
    UDI-DI
    00889024241626
    PMA / PMN Number
    K172524
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: UNKNOWN TIBIAL PLATE, #ITEM UNKNOWN, #LOT UNKNOWN. THERAPY DATE: (B)(6) 2025 G2: FOREIGN - EVENT OCCURRED IN JAPAN. 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 THAT DESPITE MULTIPLE ATTEMPTS TO INSERT THE ARTICULAR SURFACE IMPLANT WHILE CAREFULLY NOTING THE INSERTION DIRECTION, IT WOULD NOT SEAT. UPON CHECKING THE SHAPE OF THE SURFACE, IT APPEARED THAT IT HAD BECOME DEFORMED. THEREFORE, A NEW IMPLANT OF THE SAME SIZE WAS OPENED AND USED INSTEAD. THERE WAS NO PATIENT INJURY AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1959266 PSN ASF CR 10MM VE R 3-11 EF PROSTHESIS, KNEE MBH ZIMMER ORTHOPAEDIC MFG. LTD. 67152186 00889024241626

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11 NARRATIVE