BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PSN MC VE ASF R 12MM 8-11/EF

    MDR report key: 23840326 · Received December 18, 2025

    Report

    Report Number
    3007963827-2025-00518
    Event Type
    Injury
    Date Received
    December 18, 2025
    Date of Event
    December 1, 2025
    Report Date
    February 16, 2026
    Manufacturer
    ZIMMER ORTHOPAEDIC MFG. LTD.
    Product Code
    MBH
    UDI-DI
    00889024468436
    PMA / PMN Number
    K150090
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G2: FOREIGN - EVENT OCCURRED IN AUSTRALIA. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT. UPDATED: B4,B5,D2,G1,G2,G3,G6,H1,H2,H3,H5,H6. - NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. - REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. - INSUFFICIENT INFORMATION PROVIDED. UNABLE TO PERFORM A COMPATIBILITY CHECK. - REVIEW OF COMPLAINT HISTORY IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEM AND NO ADDITIONAL COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATION. COMPLAINTS ARE MONITORED THROUGH MONTHLY COMPLAINT REVIEW (REFERENCE (B)(4) IN ORDER TO IDENTIFY POTENTIAL ADVERSE TRENDS. - MEDICAL RECORDS WERE NOT PROVIDED. - A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT UNDERWENT A KNEE REVISION APPROXIMATELY A YEAR POST-IMPLANTATION DUE TO INSTABILITY, A CHANGE OF POLY WAS REQUIRED. SWAPPED THE UC 11MM WITH UC 14MM. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2208020 PSN MC VE ASF R 12MM 8-11/EF PROSTHESIS, KNEE MBH ZIMMER ORTHOPAEDIC MFG. LTD. 66689203 00889024468436

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Unknown Required Intervention| H