BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PSN ASF CPS 12MM VE R 6-9 EF

    MDR report key: 23681716 · Received December 1, 2025

    Report

    Report Number
    3007963827-2025-00478
    Event Type
    Malfunction
    Date Received
    December 1, 2025
    Date of Event
    November 6, 2025
    Report Date
    May 5, 2026
    Manufacturer
    ZIMMER ORTHOPAEDIC MFG. LTD.
    Product Code
    MBH
    UDI-DI
    00889024244580
    PMA / PMN Number
    K123459
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10- MEDICAL PRODUCT: PSN ASF CPS 10MM VE R 6-9 EF; ITEM# 42522600710; LOT# 67457792. G2- SPAIN. H3- CUSTOMER HAS INDICATED THAT THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 AN ARTICULAR SURFACE WOULD NOT ASSEMBLE WITH THE TIBIAL TRAY DURING SURGERY. WHEN IMPLANTING THE INSERT, IT DID NOT FIT IN THE TIBIA, AND IT CREATED A POSTERIOR SLOT ON THE UNDERSIDE OF THE POLYETHYLENE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154576 PSN ASF CPS 12MM VE R 6-9 EF PROSTHESIS, KNEE MBH ZIMMER ORTHOPAEDIC MFG. LTD. 66691467 00889024244580

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown