BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    UNKNOWN NEXGEN FEMORAL COMPONENT

    MDR report key: 22642266 · Received July 29, 2025

    Report

    Report Number
    0001822565-2025-02683
    Event Type
    Injury
    Date Received
    July 29, 2025
    Date of Event
    October 16, 2024
    Report Date
    April 14, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: UNKNOWN - UNKNOWN NEXGEN ARTICULAR SURFACE - UNKNOWN. UNKNOWN - UNKNOWN NEXGEN TIBIAL COMPONENT - UNKNOWN. G2 : CITATION : MADANIPOUR S, HOWARD LC, MASRI BA, GREIDANUS NV, GARBUZ DS, NEUFELD ME. OUTCOMES OF LINER EXCHANGE VERSUS COMPONENT REVISION FOR THE TREATMENT OF STIFFNESS FOLLOWING PRIMARY TOTAL KNEE ARTHROPLASTY. THE JOURNAL OF ARTHROPLASTY. 2025 APR 1;40(4):1014-20. DOI: 10.1016/J.ARTH.2024.10.014 G2 : FOREIGN COUNTRY : CANADA. H6 : MECHANICAL (G04) - FEMUR. 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.

    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

    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. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT 23 PATIENTS UNDERWENT AN INITIAL KNEE SURGERY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT UNDERWENT A COMPONENT REVISION DUE TO STIFFNESS AND LIMITED RANGE OF MOTION. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79164 UNKNOWN NEXGEN FEMORAL COMPONENT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H SEE H11.