BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERSONA MC VE ASF L 13MM 8-11/EF

    MDR report key: 23292029 · Received October 15, 2025

    Report

    Report Number
    3007963827-2025-00409
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    May 19, 2025
    Report Date
    October 14, 2025
    Manufacturer
    ZIMMER ORTHOPAEDIC MFG. LTD.
    Product Code
    MBH
    UDI-DI
    00889024469327
    PMA / PMN Number
    K150090
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL EVALUATION COULD NOT BE PERFORMED. THE SOURCE OF THE DEBRIS CANNOT BE CONFIRMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. REPORTED EVENT IS NOT RELATED TO A COMBINATION OF PRODUCTS; THEREFORE, A COMPATIBILITY REVIEW IS NOT APPLICABLE. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THE REPORTED PART AND PART LOT COMBINATIONS. MEDICAL RECORDS WERE NOT PROVIDED. THE EVENT IS NOT CONFIRMED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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. THIS EVENT WAS INITIALLY REPORTED UNDER A DIFFERENT MANUFACTURER NUMBER IN MDR: 0001822565-2025-01571.

    Description of Event or Problem · 0

    IT WAS REPORTED A HAIR WAS FOUND INSIDE THE IMPLANT PACKAGING. NO PATIENT HARM OR IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2018738 PERSONA MC VE ASF L 13MM 8-11/EF PROSTHESIS, KNEE MBH ZIMMER ORTHOPAEDIC MFG. LTD. 66561246 00889024469327

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female