BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERSONA MC VE ASF L 10MM 4-5/EF

    MDR report key: 23280476 · Received October 15, 2025

    Report

    Report Number
    3007963827-2025-00405
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    September 16, 2025
    Report Date
    February 13, 2026
    Manufacturer
    ZIMMER ORTHOPAEDIC MFG. LTD.
    Product Code
    MBH
    UDI-DI
    00889024469136
    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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: A1; A2; A3; B4; B5; D2; G1; G3; G6; H1; H2; H3; H4; H6. THE REPORTED EVENT COULD NOT BE CONFIRMED. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED.. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. MEDICAL RECORDS WERE NOT PROVIDED. ROOT CAUSE HAS BEEN IDENTIFIED AS OFF LABEL USE BETWEEN ITEM 42512100610 LOT 65712648 (PSN MC VE ASF L 10MM 4-5/EF) AND ITEM 42502806601 LOT 67093604 (FEMUR TRABECULAR METAL CRUCIATE RETAINING (CR) STANDARD POROUS) AND THESE ARE NOT COMPATIBLE AS PER IFU. 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 SIZE E TIBIA LOT# UNK. UNKNOWN SIZE 9 FEMUR LOT# UNK. G2: AUSTRALIA. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE WAS REQUESTED BUT NOT RETURNED BY THE FACILITY. 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 THE HCP COMPLETED THE CASE WITHOUT MANUFACTURER AWARENESS. THE MANUFACTURER REP WAS NOT NOTIFIED OF THE SURGERY AHEAD OF TIME. UPON RECEIVING USAGE NOTIFICATION, THE MANUFACTURER REP NOTICED THE ARTICULAR SURFACE INSERTED WAS NOT COMPATIBLE WITH CHOSEN FEMORAL IMPLANT. A REVISION SURGERY TO COMPLETE A POLY EXCHANGE, TO A FULLY COMPATIBLE ARTICULAR SURFACE WAS COMPLETED WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183113 PERSONA MC VE ASF L 10MM 4-5/EF PROSTHESIS, KNEE MBH ZIMMER ORTHOPAEDIC MFG. LTD. 65712648 00889024469136

    Patients

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