BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PSN MC VE ASF L 10MM 8-11/GH

    MDR report key: 23897238 · Received December 26, 2025

    Report

    Report Number
    3007963827-2025-00537
    Event Type
    Injury
    Date Received
    December 26, 2025
    Date of Event
    December 12, 2025
    Report Date
    March 25, 2026
    Manufacturer
    ZIMMER ORTHOPAEDIC MFG. LTD.
    Product Code
    MBH
    UDI-DI
    00889024469372
    PMA / PMN Number
    K150090
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    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,H6 THE CMP WAS NOT CONFIRMED NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. ART SURFACE AND FEMORAL: REVIEW OF COMPLAINT HISTORY IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEMS AND PART AND LOT COMBINATIONS. COMPLAINTS ARE MONITORED THROUGH MONTHLY COMPLAINT REVIEW) 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: PSN FEM CR , #ITEM 42502806801, #LOT 66327510. PSN TIB POR 2 PEG, #ITEM 42530007901, #LOT 66247299. HDLESS TRC DRILL PIN, #ITEM 00-5901-020-00, #LOT 67268909. THIN OSTEOTOME BLADE, #ITEM 47-9986-021-21, #LOT 56732084. PSN REV FEM CMT, #ITEM 42-5046-066-11, #LOT 67052457. PSN REV STR SMTH STEM, #ITEM 42-5600-135-14, #LOT 64363807. TM TIBIAL CENTRAL CONE, #ITEM 42-5450-005-13, #LOT 65749802. PSN REV TIB FIX NP, #ITEM 42-5420-079-01, #LOT 67368312. PSN REV STR SMTH STEM, #ITEM 42-5600-135-12, #LOT 64363803. PSN REV CCK VE. #ITEM 42-5128-009-12, #LOT 67458210. THERAPY DATE: (B)(6) 2025. AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT UNDERWENT A TOTAL KNEE REVISION APPROXIMATELY 22 MONTHS POST-IMPLANTATION DUE TO INSTABILITY AND PAIN. THE PATIENT HAD BEEN DOING WELL UNTIL APPROXIMATELY 12 MONTHS POST-IMPLANTATION, WHEN PAIN AND A SENSE OF INSTABILITY DEVELOPED. CLINICAL AND RADIOGRAPHIC ASSESSMENT INDICATED THE COMPONENTS APPEARED SATISFACTORY, AND THE COMPLAINTS WERE UNEXPLAINED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2319896 PSN MC VE ASF L 10MM 8-11/GH PROSTHESIS, KNEE MBH ZIMMER ORTHOPAEDIC MFG. LTD. 65552273 00889024469372

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H SEE H11 NARRATIVE.