BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    UNKNOWN NEXGEN TIBIAL COMPONENT

    MDR report key: 22203196 · Received June 13, 2025

    Report

    Report Number
    0001822565-2025-01927
    Event Type
    Injury
    Date Received
    June 13, 2025
    Date of Event
    January 17, 2025
    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
    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: B4; B5; D2; G1; G3; G6; H1; H2; H3; H6. ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION AND NO FURTHER INFORMATION HAS BEEN PROVIDED. THE EVENT CANNOT BE CONFIRMED. NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORD WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. MEDICAL RECORDS WERE NOT PROVIDED. 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

    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). D10: UNKNOWN - UNKNOWN NEXGEN FEMORAL COMPONENT - UNKNOWN. UNKNOWN - UNKNOWN NEXGEN ARTICULAR SURFACE - UNKNOWN. G2: FOREIGN COUNTRY: IRAN. G2: VAZIRI, ARASH SHARAFAT ET AL. THE IMPACT OF CEMENTING TECHNIQUES ON IMPLANT LONGEVITY IN RELATION TO KEEL LENGTH IN PERSONA AND NEXGEN KNEE ARTHROPLASTY: A COMPREHENSIVE STUDY. ARTHROPLASTY TODAY. 2025 FEB 1; 31:101608. DOI: HTTPS://DOI.ORG/10.1016/J.ARTD.2024.101608. 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.

    Description of Event or Problem · 0

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

    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 IN A JOURNAL ARTICLE THAT THREE PATIENTS DEVELOPED ASEPTIC LOOSENING AND REQUIRED UNIPOLAR TIBIAL REVISION. EACH PATIENT REPORTED A PERIOD OF INITIAL PAINLESSNESS AFTER THE INITIAL SURGERY AND THE GRADUAL ONSET OF START-UP PAIN AGGRAVATED BY WEIGHT BEARING. THE FEMORAL COMPONENT WAS WELL FIXED IN ALL KNEES AND THERE WAS NO EVIDENCE OF MACROSCOPIC POLYETHYLENE WEAR. IN ALL PATIENTS, THE TIBIAL COMPONENT WAS NOTICEABLY LOOSE, AND IN ALL CASES, FAILURE ENSUED AT THE BONE-CEMENT INTERFACE. NONE OF THE PATIENTS IN THIS GROUP EXPERIENCED EARLY (DURING THE FIRST 24 MONTHS) LOOSENING. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343086 UNKNOWN NEXGEN TIBIAL COMPONENT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. UNKNOWN

    Patients

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