BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 23523296 · Received November 11, 2025

    Report

    Report Number
    3007963827-2025-00450
    Event Type
    Malfunction
    Date Received
    November 11, 2025
    Date of Event
    August 20, 2025
    Report Date
    November 11, 2025
    Manufacturer
    ZIMMER ORTHOPAEDIC MFG. LTD.
    Product Code
    MBH
    UDI-DI
    00889024468498
    PMA / PMN Number
    K150090
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 42532008302, PSN TIB STM 5 DEG SZ H R, LOT 67153738. THE REPORTED EVENT WAS CONFIRMED VIA PHOTOGRAPH. VISUAL EXAMINATION OF THE PROVIDED PICTURE SHOWS THAT THE DOVETAIL FEATURE IS COMPRESSED AND FLARED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. DAMAGE TO THE ARTICULAR SURFACE CAN OCCUR IF THE ARTICULAR SURFACE IS NOT CORRECTLY PLACED AND ORIENTED BEFORE PUSHING IT USING THE INSERTER INSTRUMENT. DETAILED INSTRUCTIONS FOR INSERTING THE ARTICULAR SURFACE ARE PROVIDED IN THE PERSONALIZED KNEE SURGICAL TECHNIQUE. THE ROOT CAUSE IS ATTRIBUTED TO USE ERROR. 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 THE POLY WAS DAMAGED, AND ASSUMED MANUFACTURING DEFICIENCY BY THE REPORTER. SURGERY WAS COMPLETED WITH A SECOND DEVICE. THERE WAS NO IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1901975 PSN MC VE ASF R 10MM 8-11/GH PROSTHESIS, KNEE MBH ZIMMER ORTHOPAEDIC MFG. LTD. 67221423 00889024468498

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male