BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERSONA ASF CPS 14MM VE R 6-9 EF

    MDR report key: 23366722 · Received October 23, 2025

    Report

    Report Number
    0001822565-2025-03832
    Event Type
    Injury
    Date Received
    October 23, 2025
    Date of Event
    September 25, 2025
    Report Date
    December 4, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBH
    UDI-DI
    00889024244603
    PMA / PMN Number
    K123459
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPON RECEIPT OF ADDITIONAL INFORMATION AND REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT SHOULD BE VOIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). D2, D4, G4: DILIGENCE IS IN PROCESS TO PROVIDE PRODUCT IDENTIFICATION INFORMATION; HOWEVER, NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME. D10: UNK FEMORAL LOT# UNK, UNK TIBIAL LOT# UNK. G2: AUSTRALIA. THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A REVISION FOR UNKNOWN REASONS. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1545671 PERSONA ASF CPS 14MM VE R 6-9 EF PROSTHESIS, KNEE MBH ZIMMER BIOMET, INC. 64804586 00889024244603

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R SEE H11 NARRATIVE.