BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK PERSONA TIBIA

    MDR report key: 22286263 · Received June 18, 2025

    Report

    Report Number
    0001822565-2025-02008
    Event Type
    Injury
    Date Received
    June 18, 2025
    Date of Event
    January 17, 2025
    Report Date
    July 22, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) G2: IRAN. D2, D4, G4: ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION, AND NO FURTHER INFORMATION HAS BEEN PROVIDED. THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. D10: ADDITIONAL ASSOCIATED PRODUCTS. UNK KNEE FEMORAL LOT# UNK, UNK KNEE BEARING LOT# UNK. ARASH SHARAFAT VAZIRI, MDA, B, MOHAMMAD NAGHI TAHMASEBI, MDA, B, HOSEINALI HADI, MDC, SINA JAVIDMEHR, MDD, SOHRAB KEYHANI, MDE, ZAHRA VAHDATI, MDA, HOSSEIN NEMATIAN, MDA, B, YALDA FARAHMAND, MD. THE IMPACT OF CEMENTING TECHNIQUES ON IMPLANT LONGEVITY IN RELATION TO KEEL LENGTH IN PERSONA AND NEXGEN KNEE ARTHROPLASTY: A COMPREHENSIVE STUDY. ARTHROPLASTY TODAY 31 (2025) 101608. JOURNAL HOMEPAGE: HTTP://WWW.ARTHROPLASTYTODAY.ORG/.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED, UPDATED: B4, B5, G3, G6, H1, H2, H3, H6, H11. NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. INSUFFICIENT INFORMATION PROVIDED. UNABLE TO PERFORM A COMPATIBILITY CHECK. COMPLAINT HISTORY REVIEW CANNOT BE PERFORMED WITHOUT PRODUCT IDENTIFICATION. MEDICAL RECORDS WERE NOT PROVIDED. COMPLAINT IS NOT CONFIRMED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH A JOURNAL ARTICLE THAT THREE OF THE PATIENTS ENCOUNTERING A LOOSENED TIBIAL IMPLANT ALSO COMPLAINED OF SUBJECTIVE KNEE INSTABILITY. PHYSICAL EXAM SHOWED CORONAL PLANE LAXITY AND KNEE EFFUSION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

    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
    747372 UNK PERSONA TIBIA PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R SEE H11 NARRATIVE.