BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERSONA MC VE ASF L 11MM 6-7/CD

    MDR report key: 23509592 · Received November 10, 2025

    Report

    Report Number
    3007963827-2025-00446
    Event Type
    Injury
    Date Received
    November 10, 2025
    Report Date
    March 3, 2026
    Manufacturer
    ZIMMER ORTHOPAEDIC MFG. LTD.
    Product Code
    MBH
    UDI-DI
    00889024468986
    PMA / PMN Number
    K150090
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    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; H10 THE EVENT IS 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 PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: PATIENT PRESENTED WITH CHRONIC LEFT KNEE PAIN 10 MONTHS POST TKA. PAIN IS DESCRIBED AS CONSISTENT AND WORSENS WITH ACTIVITY. PAIN IS LOCATED IN THE ANTERIOR AND POSTERIOR ASPECTS OF KNEE WITH GRINDY SENSATION AND NOISE WHEN WALKING, NOTES A ''LUMPY' FEELING WHEN SITTING, AND HAS PERSISTENT NUMBNESS ON LATERAL ASPECT OF KNEE. PATIENT MANAGES PAIN WITH TYLENOL. ON EXAM, THERE WAS TENDERNESS IN THE POSTEROLATERAL REGION WITH BUMP/MASS TENDER AND HARD IN THIS REGION. X-RAYS SHOWED SLIGHT JOINT EFFUSION, HETEROTOPIC OSSIFICATION REDEMONSTRATED POSTERIOR TIBIA THAT IS SLIGHTLY PROGRESSED. THERE WAS NO FRACTURE, LOOSENING, OR WEAR SEEN. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED FROM A CLINICAL STUDY THAT THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 10 MONTHS POST-IMPLANTATION, THE PATIENT DEVELOPED CHRONIC LEFT KNEE PAIN ACCOMPANIED BY A GRINDING SENSATION AND NOISE WHEN WALKING. PERSISTENT NUMBNESS IN THE LATERAL ASPECT OF THE KNEE WAS ALSO REPORTED. THE PATIENT MANAGED THESE SYMPTOMS WITH TYLENOL. NO ADDITIONAL SURGICAL INTERVENTION WAS PERFORMED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1963406 PERSONA MC VE ASF L 11MM 6-7/CD PROSTHESIS, KNEE MBH ZIMMER ORTHOPAEDIC MFG. LTD. 66680466 00889024468986

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other