BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERSONA MC VE ASF R 16MM 8-11/EF

    MDR report key: 23336166 · Received October 20, 2025

    Report

    Report Number
    3007963827-2025-00416
    Event Type
    Injury
    Date Received
    October 20, 2025
    Date of Event
    October 8, 2025
    Report Date
    January 21, 2026
    Manufacturer
    ZIMMER ORTHOPAEDIC MFG. LTD.
    Product Code
    MBH
    UDI-DI
    00889024468467
    PMA / PMN Number
    K150090
    Adverse Event
    Yes
    Product Problem
    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. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D2; G1; G3; G6; H1; H2; H3; H4; H6. THE EVENT CANNOT BE CONFIRMED. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED A PSN MC VE ARTICULAR SURFACE. THE DEVICE SHOWS SIGNS OF USE SUCH AS SCRATCHES. THE INTRA-OP PHOTO SHOWS A BEARING THAT IS NOT SEATED IN THE TIB TRAY, HOWEVER DISASSOCIATION CANNOT BE CONFIRMED VIA THIS PHOTO. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. 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 REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: UNKNOWN - UNKNOWN FEMORAL COMPONENT - UNKNOWN. UNKNOWN - UNKNOWN TIBIAL COMPONENT - UNKNOWN. G2 : FOREIGN COUNTRY: AUSTRALIA. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 THE PATIENT UNDERWENT AN INITIAL KNEE SURGERY. DURING THE POST-OP CONSULT, THE SURGEON NOTED THAT THERE WAS A SMALL FLEXION DEFORMITY OF APPROXIMATELY 5 DEGREES AND CT IMAGING REVEALED THAT THE POLY WAS NOT FIXED TO THE BASEPLATE. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 2 MONTHS POST-OP. THE POLY WAS REVISED TO A LARGER POLY. IT WAS NOTED THAT THE SURGEON SPENT A CONSIDERABLE AMOUNT OF TIME REMOVING SOFT TISSUE AND BONE FROM THE POSTERIOR TIBIA, HOWEVER, THERE WAS NO SURGICAL DELAY. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340341 PERSONA MC VE ASF R 16MM 8-11/EF PROSTHESIS, KNEE MBH ZIMMER ORTHOPAEDIC MFG. LTD. 67052240 00889024468467

    Patients

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