BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERSONA

    MDR report key: 23632868 · Received November 24, 2025

    Report

    Report Number
    0001822565-2025-04271
    Event Type
    Injury
    Date Received
    November 24, 2025
    Date of Event
    October 30, 2025
    Report Date
    December 30, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K172524
    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: E1, G3; H2; H6. THE REPORTED EVENT COULD NOT BE CONFIRMED DUE TO LACK OF PRODUCT/INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE NOT PROVIDED. THE DEVICE HISTORY RECORD WAS NOT REVIEWED DUE TO LACK OF LOT NUMBER/OTHER REASON FROM SUMMARY. REVIEW OF COMPLAINT HISTORY IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEMS. HOWEVER, AS THE LOT NUMBER IS UNKNOWN, AN ADDITIONAL REVIEW COULD NOT BE PERFORMED. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). G2: FOREIGN ¿ AUSTRALIA. D4: ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION AND NO FURTHER INFORMATION HAS BEEN PROVIDED. D10: PN 42522000410 LN UNKNOWN PERSONA® VIVACIT-E. PN 42532006702 LN UNKNOWN PERSONA® NATURAL TIBIA. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. SUGGESTED COMPONENT CODE: MECHANICAL (G04) ¿ FEMUR.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED WAS REPORTED PATIENT WAS REVISED APPROXIMATELY 4 YEARS POST IMPLANTATION DUE TO INSTABILITY AND PAIN. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2629818 PERSONA PROTHESIS, KNEE JWH ZIMMER BIOMET, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention| H