BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DISTAL FEMORAL COMPONENT

    MDR report key: 22829626 · Received August 18, 2025

    Report

    Report Number
    0001825034-2025-02498
    Event Type
    Injury
    Date Received
    August 18, 2025
    Date of Event
    June 17, 2025
    Report Date
    August 28, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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, G3, H2, H6. D4: ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION, AND NO FURTHER INFORMATION HAS BEEN PROVIDED. THE REPORTED EVENT COULD NOT BE CONFIRMED WITH THE INFORMATION PROVIDED; NO PRODUCT RETURNED, OR IMAGES PROVIDED, THUS VISUAL AND DIMENSIONAL ANALYSES COULD NOT BE MADE. NO MEDICAL RECORDS WERE RECEIVED. REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED AS PART IDENTIFICATION WAS NOT PROVIDED. A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). B3: DATE OF PUBLICATION. D10: UNKNOWN ADAPTER, UNKNOWN TIBIAL BODY, UNKNOWN FEMORAL STEM, UNKNOWN SPINDLE, UNKNOWN BEARING, UNKNOWN BUSHING, UNKNOWN YOKE, UNKNOWN AXLE, UNKNOWN LOCK PIN, UNKNOWN FEMORAL BUSHING. G2: LITERATURE CITATION: DAY, Y., THOMPSON, A.R., ANDAYA, V.R. (2025). SURVIVAL OF PROXIMAL TIBIAL ENDOPROSTHESIS USING COMPRESSIVE OSSEOINTEGRATION: A MULTI-INSTITUTION RETROSPECTIVE STUDY. JOURNAL OF SURGICAL ONCOLOGY, 2025, 1-10. HTTPS://DOI.ORG/10.1002/JSO.70013. H6: PROPOSED COMPONENT CODE: MECHANICAL (G04) - FEMUR. CUSTOMER HAS INDICATED THAT 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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION TO REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH A JOURNAL ARTICLE THAT APPROXIMATELY 5 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT A REVISION DUE TO ASEPTIC LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1960903 UNKNOWN DISTAL FEMORAL COMPONENT PROSTHESIS, KNEE KWA ZIMMER BIOMET, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Unknown Required Intervention| H SEE H11.