BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PSN ASF PS 14MM VE R 6-9 CD

    MDR report key: 23586484 · Received November 18, 2025

    Report

    Report Number
    3007963827-2025-00468
    Event Type
    Malfunction
    Date Received
    November 18, 2025
    Date of Event
    October 30, 2025
    Report Date
    April 23, 2026
    Manufacturer
    ZIMMER ORTHOPAEDIC MFG. LTD.
    Product Code
    MBH
    UDI-DI
    00889024243637
    PMA / PMN Number
    K121771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G2- JAPAN 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.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. UPDATED: B4, B5, D2B, D9, G1, G2, G3, G6, H1, H2, H3, H6, AND H11 VISUAL EXAMINATION OF THE RETURNED PRODUCT SHOWS THAT IT EXHIBITS SIGNS OF USE (DINGS AND SCRATCHES ON THE BOTTOM SURFACE AS WELL AS IN AND AROUND THE EXTRACTION SLOT). THE DOVETAIL FEATURE SHOWS SIGNS OF DAMAGE (BOTH COMPRESSED AND FLARED) AS WELL AS NUMEROUS DINGS. MEDICAL RECORDS WERE NOT PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. DAMAGE TO THE ARTICULAR SURFACE CAN OCCUR IF THE ARTICULAR SURFACE IS NOT CORRECTLY PLACED AND ORIENTED BEFORE PUSHING IT USING THE INSERTER INSTRUMENT. THE ROOT CAUSE IS ATTRIBUTED TO A FAILURE TO FOLLOW INSTRUCTIONS. THIS COMPLAINT IS CONFIRMED. 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 THAT AN ARTICULAR SURFACE DIDN¿T MATE WITH TIBIAL PLATE. THE SURGEON CAREFULLY TRIED TO INSERT IT, AFTER THAT, IT WAS DISCOVERED THAT THE BACK SIDE OF THE ARTICULAR SURFACE WAS DEFORMED. THE SURGERY WAS COMPLETED WITH ANOTHER ARTICULAR SURFACE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1863228 PSN ASF PS 14MM VE R 6-9 CD PROSTHESIS, KNEE MBH ZIMMER ORTHOPAEDIC MFG. LTD. 65645172 00889024243637

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown