BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    UNKNOWN PERSONA TIBIAL COMPONENT

    MDR report key: 22194526 · Received June 12, 2025

    Report

    Report Number
    0001822565-2025-01891
    Event Type
    Injury
    Date Received
    June 12, 2025
    Date of Event
    December 12, 2024
    Report Date
    March 30, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B4, B5, D2, G1, G3, G6, H1, H2, H11. H1: THIS MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE LITERATURE MDR REPORTING REVIEW AND REMEDIATION EFFORT BASED ON MDR REPORTING PROCESS AND FDA ADVERSE EVENT REPORTING REQUIREMENT. CAPA -07984 WAS OPENED ON FEB 27, 2026, TO ADDRESS CORRECTIONS. DEVICE PERFORMANCE AND/OR RISK PROFILE ARE NOT IMPACTED. IF ANY FURTHER INFORMATION 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). VAZIRI, A. S., TAHMASEBI, M. N., HADI, H., JAVIDMEHR, S., KEYHANI, S., VAHDATI, Z., NEMATIAN, H., FARAHMAND, Y. (2025) 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(101608)1-7 HTTPS://DOI.ORG/10.1016/J.ARTD.2024.101608. D10 - CONCOMITANT DEVICES - UNKNOWN PERSONA ARTICULAR SURFACE CATALOG #: NI LOT #: NI, UNKNOWN PERSONA FEMORAL COMPONENT CATALOG #: NI LOT #: NI. E1 - CORRESPONDENCE AUTHOR. G2 - REPORT SOURCE - FOREIGN: EVENT OCCURRED IN IRAN. THE COMPLAINANT HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, G3, G6, H2, H6, H11. D4 - ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION AND NO FURTHER INFORMATION HAS BEEN PROVIDED. THE PRODUCT COULD NOT BE EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS THE LOT NUMBER ASSOCIATED WITH THE REPORTED EVENT IS UNKNOWN. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. 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

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOUR (4) PATIENTS UNDERWENT KNEE ARTHROPLASTY REVISIONS OF THE TIBIAL COMPONENTS GREATER THAN TWO (2) YEARS POST-OPERATIVELY TO ADDRESS ASEPTIC TIBIAL COMPONENT LOOSENING AND PAIN WHILE WEIGHT-BEARING. THE FEMORAL COMPONENTS WERE FOUND TO BE WELL-FIXED AND THERE WAS NO EVIDENCE OF POLYETHYLENE WEAR, BUT THE TIBIAL COMPONENTS WERE IDENTIFIED TO BE NOTICEABLY LOOSE AT THE BONE-CEMENT INTERFACE. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL 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
    2032958 UNKNOWN PERSONA TIBIAL COMPONENT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

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